News Type: Newsletter

March 2024 Newsletter

In the Spotlight

The Clinical Research Glossary: New Words, New Opportunities

Please join us on Tuesday, April 2, from 12 – 1 PM ET to celebrate the MRCT Center’s newly expanded Clinical Research Glossary.

This plain-language global standard has been developed in collaboration with CDISC to benefit research participants and anyone interested in developing easy-to-understand research materials.

With over 160 definitions, including images and supportive information, the MRCT Center’s Clinical Research Glossary has been designed to support the communication of clear research information, along with tailored, shareable images to foster engagement and understanding.

Learn more about:

  • Building trust and transparency with participants through plain language information sharing.
  • The dedicated team members and robust process that is followed to create this global standard.
  • Strategies and approaches to implement the Clinical Research Glossary content into patient-facing materials. 

We look forward to sharing this important expanded resource with you.

Click here to register.

Joint Task Force for Clinical Trial Competency (JTF)

Please join us on Thursday, June 6, from 9 – 11:00 AM ET for the virtual biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF). We will hear about a comprehensive training program in Canada based on the JTF Framework, coordinate ongoing activities, and review updates.

Please register here. 

Expanding Access to MRCT Center Resources

As part of a recent update, we implemented a new Accessibility widget that allows users to access our website in over 50 languages and modify the user experience for many accessibility profiles. Explore this functionality by clicking on the Accessibility Menu icon on any page of the MRCT Center website.

We continue to add downloadable PDF translations of many of our resources, too, including the JTF Framework, now available in 10 languages here, and several pediatric informational brochures, available in Arabic and Urdu, as well as other languages.

Events & Presentations

March 7: The MRCT Center held a webinar to introduce the Research Ethics Action Collaborative for HRPPs (REACH) project, an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants—tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. Hayat Ahmed organized the webinar, and Barbara Bierer (MRCT Center), Ivy R. Tillman (PRIM&R), Michelle Feige (AAHRPP), and Martha F. Jones (MGB) presented. Webinar assets are available here, including the recording, slides, list of resources, Q&A, and a survey.

March 12: Barbara Bierer presented on the limitations of, and possible solutions to, regulatory pathways that involve non-life-threatening research in which consent is not feasible. Neither the FDA nor HHS has a readily available path to permit clinical research in settings that do not fit the specified exceptions from informed consent (EFIC) guidance (e.g., emergent settings in which consent is not possible but the condition is not life-threatening and available treatments are unproven or unsatisfactory). The conference, convened by the National Institutes of Neurological Diseases and Stroke (NINDS), NIH, explored the necessary components and guardrails that would allow this necessary research to proceed.

March 13: Barbara Bierer moderated a compelling session at DIA Europe 2024 entitled “Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review.” She was joined by colleagues Sneha Dave (Generation Patient, USA), Christina Bucci-Rechtweg (Novartis, USA), Siri Wang (Norwegian Medical Products Agency, Norway), and Dominik Karres (European Medicines Agency, The Netherlands) in a discussion that highlighted the importance—and challenges—of ensuring access of safe and effective medicines to children.  

March 22: Dr. Willyanne DeCormier Plosky conducted a training on the Inclusion of People with Disabilities in Clinical Research with Fellows from the Leadership Education in Neurodevelopmental and Related Disabilities (The LEND program) at Boston Children’s Hospital Institute for Community Inclusion. 

March 28: Sylvia Baedorf Kassis was a panelist for TransCelerate’s “Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package” webinar, where attendees learned about general considerations to enable data return to clinical study participants. 

March 28: Barbara Bierer was a panelist at the “Fostering Collaboration to Advance Representation Enrollment in Clinical Trials” webinar hosted by the Duke-Margolis Institute for Health Policy.

March 29: Dr. Barbara Bierer participated in a virtual roundtable co-hosted by FasterCures/Milken Institute, the Reagan Udall Foundation, the Clinical Trials Transformation Initiative, and the Foundation for NIH on “Imperatives for US Clinical Research Leadership and Coordination.” This virtual roundtable shared several initiatives underway across the government, private- and nonprofit sectors to build and coordinate clinical research infrastructure and capacity and to articulate and gain alignment around collective goals for the immediate term in 2024 while laying the groundwork for the future.

April 2, 12 – 1 PM ET: Clinical Research Glossary: New Words, New Opportunities webinar. (See Spotlight above). Click here to register.

April 4-5: Barbara Bierer will present at the Decentralized Clinical Trial’s two-day in-person workshop hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA.

  • April 4: Decentralized Clinical Trials: An Evolving Landscape Decentralized Clinical Trials: An Evolving Landscape will review the regulatory, ethical, and operational challenges in the planning and execution of such trials. The roles and responsibilities of PIs and other research and clinical team members will be discussed, as well as considerations for IRBs and institutional human research protection programs (HRPPs). 
  • April 5: Ethics Review of Decentralized Clinical Trials Dr. Bierer will review the ethical and regulatory responsibilities of sponsors, investigators, institutional review boards, and other stakeholders when planning and implementing DCTs. 

April 9: Dr. Willyanne DeCormier Plosky will participate in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit: a plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research” and a breakout session entitled “Inclusivity Forum: People with Disabilities.” 

April 11, 10 AM -2 PM (Closed Meeting). Barbara Bierer will discuss, “The Clinical Trial Ecosystem, IRB, Investigators, Health Systems and Regulatory Authority – Roles, Responsibilities, and Requirements” at the Clinical Trials & Operational Considerations and Excellence Workshop, a workshop aimed at deepening the understanding of the regulatory system for clinical trials in Costa Rica and the United States, and its global context, co-organized by the US FDA and Costa Rican Ministry of Health.

May 3, 1:30-4 PM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Real World Evidence (RWE) and Emerging Trends in Clinical Trial Subject Recruitment. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

Publications

March 1: In an article, “Ethical Considerations in Decentralized Clinical Trials,” published in the Journal of Bioethical Inquiry, Barbara Bierer and Sarah White summarized salient ethical issues in the design and conduct of decentralized clinical trials, including participant safety, privacy and confidentiality, consent, digital access and proficiency, and trial oversight. Given the increasing involvement of decentralized study components, it is necessary to develop processes and cooperative solutions to promote safe, ethical trials, as well as focus on decreasing burden and increasing access for all participants.  

March 21: The MRCT Center submitted public comments to support the FDA’s draft guidance, “Master Protocols for Drug and Biological Product Development: Guidance for Industry,” and addressing several areas that could benefit from further clarification and guidance, highlighting the need for specificity in rare disease trials and informed consent practices.

MRCT Center Updates

We are thrilled to welcome four new Program Managers to our team:

Trevor Baker will be primarily involved in projects on Artificial Intelligence, Environmental Sustainability, and Platform Studies. 

Before joining the MRCT center, Trevor worked as a Research Project Manager at Boston Medical Center on a multi-regional trial in the research area of overdose prevention. 

Emina Berbic will be primarily involved in the Bioethics Collaborative, Cell and Gene Therapy, and Decentralized Clinical Trials projects.

Before joining the MRCT Center, Emina was a Project Manager at MGH, spearheading initiatives to innovate care for bipolar disorder. Her diverse background includes involvement in clinical trials within a global CRO and contributing as a graduate research assistant to the sidHARTe project, which concentrated on fortifying emergency health systems in emergency obstetric and neonatal care. Additionally, she contributed to a project addressing the double disease burden in Eswatini during her time at Columbia University.

Alex Marroquín joined the MRCT Center in March 2024 as a Program Manager. Alex is primarily involved in projects related to patient broad consent and Center communications.

Prior to joining the MRCT Center, Alex worked for Boston University/Boston Medical Center as a data analyst and research coordinator in sub-Saharan countries.

Emad Salman Shaikh will focus primarily on developing and designing a series of training modules. He is also collaborating on harmonizing efforts to build capacity for clinical research in new geographical regions.

Emad earned an MD from Pakistan and did his residency training in Orthopedics at the ACGME-I accredited Weil Cornell affiliated Hamad General Hospital in Doha, Qatar. He brings 15 years of experience in direct patient care, medical affairs, clinical trial operations, and management. Previously, he worked for Massachusetts General Hospital, among others. He has also contributed to designing studies, writing several articles, poster abstracts, book chapters, and quality improvement projects.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

February 2024 Newsletter

In the Spotlight

The MRCT Center, in collaboration with CDISC, presents the newly expanded and re-designed Clinical Research Glossary. With the dedicated efforts of numerous volunteers, content has been updated, and more than a hundred new terms have been added. Highlights include specialized information to help support participants and tailored, shareable images to foster engagement and understanding. Please join us on April 2, from 12 – 1 PM ET, to explore how this Clinical Research Glossary meets the needs of participants and the clinical research industry.

Click here to register.

Global Diversity, Equity, and Inclusion (GDEI): A Project Introduction

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center) Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, released in late 2020 and updated in 2021, outlines a principled, multi-stakeholder approach to optimize the inclusion of diverse populations in clinical research. It is accompanied by a Toolkit, including checklists, logic models and case studies, an Equity by Design metrics framework, and resources to support ethics committees. These are all living documents, and further work, such as the inclusion of people with disabilities in clinical research, is ongoing.
 
As part of this further work, the MRCT Center has widened our DEI lens from domestic to Global DEI. Over the last nine months, we have collaboratively sought to better understand how concerns around diversity, equity, and inclusion in clinical research are understood and prioritized in different countries and regions around the world and what this means for the many stakeholders involved in research conducted in multi-country contexts. We have several tools under development, including a draft Roadmap (prompts for developing a global diversity, equity, inclusion, and accessibility strategy) introduced during the [invite-only] Executive/Steering Committee meeting in December and a Diversity Action Plan (DAP) tool presented at the MRCT Annual Meeting.  
 
[Read More]

REACHing Inclusion: Pioneering Pathways in HRPPs: March 7, 12 – 1 PM ET

Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community. 

Join us for an engaging webinar on Thursday, March 7, from 12 to 1:00 PM ET. This interactive session will explore actionable strategies to operationalize inclusion efforts in HRPPs, including (1) Making the Case for Leadership, (2) Establishing a Roadmap for Change, (3) Presenting Resources, and (4) Soliciting Examples.

We welcome your collaboration in this collective endeavor to strategize and operationalize efforts within IRBs and HRPPs.

Click here to register.

Toward a Framework to Improve Diversity and Inclusion in Clinical Trials: April 23

Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes.

The MRCT Center is collaborating on an initiative with the Clinical Trials Transformation Initiative (CTTI), FasterCures, and the National Academies of Sciences Engineering and Medicine (NASEM) to catalyze system-level change and collective efforts across organizations and sectors to achieve racial and ethnic diversity in U.S. interventional clinical trials.

As part of this collaborative endeavor, a series of meetings have been held, each hosted by one of the participating institutions.

The National Academies of Sciences, Engineering, and Medicine Forum on Drug Discovery, Development, and Translation and National Cancer Policy Forum will organize a hybrid public workshop on April 23, 2024, the last of the four convenings, to explore opportunities to improve racial and ethnic diversity in clinical trials with a focus on system-level change and collective efforts across organizations and sectors. This workshop will consider strategies for equitable participation and innovative trial design to support community investment, engagement, and workforce development.

Click here to register.

2023 Annual Meeting Summary

Faculty Co-Directors Mark Barnes and Barbara Bierer and Executive Director Sarah White at the 2023 Annual Meeting

Proceedings from the MRCT Center Annual Meeting in December 2023 have been posted. The meeting included a keynote by Dr. Peter Arlett, Head of Data Analytics and Methods Task Force of the European Medicines Agency (EMA), and panel discussions on post-trial responsibilities/continued access to investigational products, an international framework for specimen sharing (the Seattle Principles), and diversity action plans and global considerations for clinical trials.  

Events & Presentations

February 12: Dr. Barbara Bierer virtually presented “The Principle of Justice in Human Participant Research” to the Neurosciences Clinical Trials Consortium. 

February 14: Barbara Bierer delivered the keynote address at the 2024 Clinical Trials Training Summit: Mastering Excellence through Innovative Competency Training, a meeting hosted by CANTRAIN, CAN-TAP-TALENT, StrokeCog and CBITN, in Montréal, Canada. Her presentation was entitled “From Theory to Practice: Development and Implementation of the JTF: Joint Task Force for Clinical Trial Competency Framework.”

February 15: Barbara Bierer presented the keynote lecture, “Striving for Sustained Change: The Principle of Justice in Human Participant Research,” at the University of North Carolina at Chapel Hill.

March 7, 12 – 1 PM ET: Representatives from the MRCT Center, Mass General Brigham, AAHRPP, and PRIM&R will discuss the Research Ethics Action Collaborative for HRPPs (REACH) initiative at a webinar. (See Spotlight above.) Click here to register. 

March 8, 11 AM – 2 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Advancing Inclusion: Integrating Pregnant and Lactating People in Research. Open to sponsors of the Bioethics Collaborative.

March 12, 8:30 AM – 4:30 PM (closed meeting): Barbara Bierer will present at the Regulatory Determinations related to Informed Consent, EFIC, and Waiver of Consent in Emergency Clinical Trials Workshop, hosted by NIH in Rockville, MD.

March 13, 10:50 AM- 12:00 Noon (16:50-18:00 CET): Barbara Bierer will moderate and present “Aligning Stakeholders to Facilitate Access to Medicines for Children: From Product Development Through HTA Review” at the DIA Europe 2024 in Brussels, Belgium.

March 22, 9 – 11:30 AM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Expanded Access (Compassionate Use) for Drugs and Devices. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

March 22, 10 – 11 AM ET (closed meeting): Dr. Willyanne DeCormier Plosky will conduct a training, “Inclusion of People with Disabilities in Clinical Research,” with Fellows from the Leadership Education in Neurodevelopmental and Related Disabilities (LEND Boston) at Boston Children’s Hospital Institute for Community Inclusion. 

March 28, 9-10 AM ET: Sylvia Baedorf Kassis will be a panelist for TransCelerate’s “Enabling Individual Participant Data Return (iPDR): An Overview of TransCelerate’s Individual Participant Data Return Package” webinar, where attendees will learn about general considerations to enable data return to clinical study participants. 

March 28, 10 AM – 2:45 PM ET: Barbara Bierer will be a panelist at the “Fostering Collaboration to Advance Representation Enrollment in Clinical Trials” webinar hosted by the Duke-Margolis Institute for Health Policy.

April 2, 12 – 1 PM ET: Clinical Research Glossary: New Words, New Opportunities webinar. (See Spotlight above). Click here to register.

April 4-5: Barbara Bierer will present at the Decentralized Clinical Trials two-day in-person workshop, hosted by the Society of Clinical Research Associates (SOCRA) in Savannah, GA.

April 9, Dr. Willyanne DeCormier Plosky will participate in two panels at the Society for Clinical Research Sites (SCRS) IncluDE Summit:

·  9:00-9:30 AM ET: Plenary session on “Equity at the Crossroads: Financial Barriers in Clinical Research.”

·  10:30 – 11:30 AM ET: Breakout session titled “Inclusivity Forum: People with Disabilities.”  

April 11, 10 AM -2 PM (Closed Meeting). Barbara Bierer will discuss, “The Clinical Trial Ecosystem, IRB, Investigators, Health Systems and Regulatory Authority – Roles, Responsibilities, and Requirements” at the Clinical Trials & Operational Considerations and Excellence Workshop, a workshop aimed at deepening the understanding of the regulatory system for clinical trials in Costa Rica and the United States, and its global context, co-organized by the US FDA and Costa Rican Ministry of Health.

Publications

February 1: In collaboration with Barbara Bierer and others, MGB authors Francis Shen and Benjamin Silverman developed a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research. The article, Returning Individual Research Results from Digital Phenotyping in Psychiatry, was published in the American Journal of Bioethics.
 
February 8: The MRCT Center submitted public comments to the World Medical Association on the Declaration of Helsinki. The WMA’s Declaration of Helsinki is an often-referenced, foundational guidance document for the clinical research enterprise. The MRCT Center submitted targeted recommendations to the WMA on areas such as health literacy, accessibility, informed consent, participant autonomy, and post-trial responsibilities (among others) in the first of two public consultation periods. We await the second public consultation with interest.
 
February 12: The MRCT Center submitted comments in response to the Department of Justice (DOJ) Notice for Proposed Rulemaking (NPRM) request to revise the regulations implementing title II of the Americans with Disabilities Act (ADA), 28 CFR part 35, in the draft, “Nondiscrimination on the Basis of Disability; Accessibility of Medical Diagnostic Equipment of State and Local Government Entities.” 

New Executive Committee Sponsorship

The MRCT Center welcomes WCG, a leading global provider of ethical and regulatory approvals and compliance services for clinical research, focusing on improving the quality and efficiency of clinical trials, to the Executive Committee of the MRCT Center.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

January 2024 Newsletter

In the Spotlight

We are delighted to announce the launch of the updated webpage dedicated to our Promoting Global Clinical Research in Children project. With our workgroup activities now complete, we are focused on presenting our findings and actively engaging in international projects. We offer a comprehensive suite of resources tailored for stakeholders who are directly involved or have an interest in pediatric clinical research. This includes our Including Young People in Research toolkit, our Guiding Principles, and a curated selection of pediatric-focused webinars, complete with recordings and summaries. Please visit our website for tools, publications, and materials supporting pediatric clinical research worldwide.

MRCT Center in Ethiopia

Left to Right: Marisol Guraiib, Consultant, WHO Headquarters; Hayat Ahmed, Program Manager, MRCT Center; Chinwe Iwu-Jaja, PhD, Pharmacist, WHO, Regional Office for Africa; Alambo Mssusa, Technical Officer, WHO, Regional Office for Africa; Barbara Bierer, MD, Faculty Director, MRCT Center; Heran Gerba, Director General, Ethiopian Food & Drug Authority (EFDA); Asnakech Alemu, Director of Product Safety, EFDA; Assefa Ejamo, Team Lead, EFDA; Kwasi A. Nyarko, PhD, Coordinator, AVAREF Secretariat, WHO, Regional Office for Africa
 
Supporting the African Vaccine Regulatory Forum (AVAREF) since 2019, Dr. Barbara Bierer and Hayat Ahmed (MRCT Center), together with Dr. Kwasi Nyarko, Alambo Mssusa, and Dr. Chinwe Iwu-Jaja (AVAREF and WHO AFRO), and Marisol Guraiib (WHO HQ Ethics Review) met in Addis Ababa, Ethiopia, on a mission recently.
 
AVAREF, a network of African national regulatory authorities and ethics committees, is dedicated to enhancing regulatory capacities and standardizing best practices for clinical trials across Africa. AVAREF has undertaken a “Clinical Trial Optimization” initiative to increase efficiencies, cooperation, partnerships, and quality of regulatory and ethical reviews of clinical trial processes. Several countries have been visited, and Dr. Bierer has joined two (Kenya, and Nigeria) of the previous evaluations.
 
The Ethiopia mission comprised a four-day assessment featuring an analysis of process, timing, and communication across the national regulatory agency, the National Research Ethics Review Board, ECs/IRBs, and Principal Investigators, culminating in final meetings encompassing discussions and recommendations to all stakeholders involved.

REACH Webinar: March 7, 12 – 1 PM ET

Introducing Research Ethics Action Collaborative for HRPPs (REACH), an initiative spearheaded by the MRCT Center, AAHRPP, PRIM&R, and Mass General Brigham. This effort aims to curate, align, and disseminate tools to advance access to and inclusion in clinical research—for all potential participants–tailored for Institutional Review Boards (IRBs), Human Research Protection Programs (HRPPs), and the broader community.

We invite you to join an engaging webinar scheduled for Thursday, March 7 from 12 – 1:00 PM ET. This interactive session will explain the motivation behind this effort and explore actionable strategies to operationalize inclusion efforts in HRPPs.

The key discussion points include:

·     Making the Case for Leadership: Understand the significance of integrating inclusion and accessibility within HRPPs and explore effective ways to articulate a compelling case that resonates with stakeholders and leadership.

·     Establishing a Roadmap for Change: Delve into the process of creating a roadmap for change, navigating institutional processes, and garnering leadership buy-in to ensure a sustainable and impactful implementation of inclusion in HRPPs.

·     Presenting Resources: Explore resources available to IRBs, HRPPs, and institutions currently freely available, and provide a means for attendees to identify additional tools needed for this work.

·     Soliciting Examples: Hear from participants about successful practices and strategies implemented within their respective institutions, fostering a dynamic exchange of insights and best practices.

Join us in this collective endeavor to actively strategize and operationalize efforts within IRBs and HRPPs. Mark your calendars for March 7th, and please register here.

The MRCT Center hosted a biannual global Joint Task Force for Clinical Trial Competency (JTF) meeting on November 14, 2023. The meeting included updates from various members of the JTF and progress reports from workgroups, including Data Management, Workforce Development, Emergency Preparedness, and an open discussion.

Click here to read the meeting proceedings and view the conference slides.

Events & Presentations

January 17: Dr. Barbara Bierer presented “Ethical Review of Decentralized Clinical Trials” at a Medable webinar related to the IRB/EC Considerations for DCT Review.

January 25: Dr. Willyanne DeCormier Plosky presented in person on “Dismantling Ableism in Clinical Research: From the Basics to Breaking News” at the University of Alabama’s 2024 Symposium on Addressing Ableism in Research, Healthcare, and Higher Education.

March 7, 12 – 1 PM ET: Representatives from the MRCT Center, Mass General Brigham, AAHRPP, and PRIM&R will discuss the Research Ethics Action Collaborative for HRPPs (REACH) initiative at a webinar. (See Spotlight above.) Click here to register.

March 8, 11 AM – 2 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Advancing Inclusion: Integrating Pregnant and Lactating People in Research. Open to sponsors of the Bioethics Collaborative.

March 22, 9 – 11:30 AM ET: Meeting of the Research, Regulatory, and Development Roundtable (R3). Topic: Expanded Access (Compassionate Use) for Drugs and Devices. Open to sponsors of the Research, Regulatory, and Development Roundtable (R3).

Publications

January 4: The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office of Research Integrity on Public Health Service Policies on Research Misconduct to urge for a fairer and more efficient process in research misconduct proceedings.
 
January 18: Barbara Bierer co-authored an article, “Education and training of clinical research professionals and the evolution of the Joint Task Force for Clinical Trial Competency” in Frontiers in Pharmacology.

New Sponsorship

The MRCT Center welcomes Bristol Myers Squibb as a new Executive Committee sponsor. Bristol Myers Squibb is a global biopharmaceutical company focused on discovering, developing, and delivering innovative medicines.

MRCT Center Updates

In January, Lindsey Henriques joined the MRCT Center as a Student Researcher in creative design. She is working to develop imagery for the Clinical Research Glossary, which will release an updated and enhanced website in late March. She will also work on several other MRCT Center projects.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

November 2023 Newsletter

In the Spotlight

Last Call! Register now for the 2023 Annual Meeting in Boston, December 13-14

Schedule highlights, in addition to programmatic updates and discussions about MRCT Center work:

·     Keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA)

·     Panel 1: Post-trial Responsibilities: Continued Access to Investigational Products

·     Panel 2: International Framework for Specimen Sharing: the Seattle Principles

·     Panel 3: Diversity Action Plans and their impact and interpretation through an international and domestic lens

·     Research, Development, and Regulatory Roundtable (R3)

·     1) Update on the GDPR, including discussion of the EU/US data privacy framework;

·     2) Considerations for Ensuring Accurate Clinical Trials Data

·     Bioethics Collaborative (BC): Gene Therapies: Probing the Ethics

Click here for a detailed agenda, the FAQ, and to register. Open to all registrants at no cost.

left to right: Yasmeen Long (FasterCures), Barbara Bierer (MRCT Center), Esther Krofah (FasterCures), Sally Okun (CTTI) and Carolyn Shore (NASEM)

Diversity Convergence Update

Barbara Bierer, Willyanne DeCormier Plosky, and Hayat Ahmed attended the 2023 Milken Institute Future of Health Summit, where Barbara Bierer spoke as a panelist during the Health Equity Convergence Session. This session was the third meeting of the Diversity Convergence Project, led by Faster Cures, the MRCT Center, CTTI, and NASEM. The discussion focused on community engagement, partnerships, and site enablement (emphasizing the business case for industry involvement), tackling implicit bias, the importance of standardized DEI outcome measures, and rethinking the significance of real-world data and clinical trials. The dialogue extended to exploring avenues for scaling successful programs like NIH’s All of Us, integrating genetic information into clinical trials, and leveraging public-private partnerships for global impact. NASEM will host the fourth meeting for DEI convergence in early Spring 2024.  

MRCT Center Faculty Co-Director Mark Barnes honored with PRIM&R Service Award

Public Responsibility in Medicine and Research (PRIM&R) announced Mark Barnes, JD, LLM, as the winner of the 2023 PRIM&R Service Award for being an inspiring and influential leader in the research field. 

During his 40-year career, Mr. Barnes has been an unparalleled leader in the areas of research misconduct, human and animal research oversight, health care law, conflict of interest, international research, and data privacy. He is a partner at Ropes &Gray LLP in Boston.

“The PRIM&R Service Award recognizes the many and varied ways that people can have a significant impact on the field. Mark Barnes has tirelessly worked to improve the integrity, safety, and rigor of global clinical trials while being dedicated to mentoring those around him,” said PRIM&R Executive Director Ivy R. Tillman, EdD, CCRC, CIP

Click here to read more.

Events & Presentations

November 30: Dr. Bierer will participate on the panel, “Post-Approval Dissemination of Clinical Study Enrollment Demographic Data to the Public” at the same virtual FDA/CTTI Public Workshop to Enhance Clinical Study Diversity meeting.

December 4 – 6: The MRCT Center at the PRIM&R Annual Conference:

December 4:

·     Dr. Bierer: “What Keeps You Up at Night: Future Frontiers in Research”; “IRB Review of Technology Used for Virtual and Virtual/Remote Clinical Trials”

·     Sylvia Baedorf Kassis: “Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information”

·     Elisa Koppelman: “Including Young People in Research: A Toolkit to Support the Intentional Inclusion of Youth Perspectives in Pediatric Clinical Trials & Product Development” 

December 5:

·     Dr. DeCormier Plosky: “It’s About Time: Inclusion of Sexual and Gender Minorities in Clinical Research”; “Accessibility by Design: Operationalizing Full Commitment to the Americans with Disabilities Act in Clinical Research Practice”

December 6:

·     Dr. Bierer: “Utilizing a System of IRB Precedent: Moving Toward Consistency and Transparency”

·     Mark Barnes: “Navigating Data and Specimen Sharing for Transnational Research”; “Building Bridges: Towards an International Framework for Specimen Sharing”

December 13 – 14: The MRCT Center Annual Meeting, including meetings of the Research, Development, and Regulatory Roundtable (R3) and Bioethics Collaborative (BC). Open to all registrants at no cost. (See Spotlight above; click here for more information and to register.)

Publications

November 10: The MRCT Center commented on the Census Bureau’s proposed American Community Survey Sexual Orientation and Gender Identity Test (the ‘Test’) as part of its ongoing American Community Survey Methods Panel Tests. The MRCT Center thanked the Bureau for its commitment to bringing Sexual Orientation and Gender Identity (SOGI) data collection to the foreground. In our response, we asked specific questions about the design of the ‘Test’ and the reliability and privacy of proxy reporting by one household member about the sexual orientation and gender identity of other household members. 
 
November 11: The MRCT Center submitted a response to the Notice for Proposed Rulemaking (NPRM) request of the Office for Civil Rights (OCR) for comments on the draft, “Discrimination on the Basis of Disability in Health and Human Service Programs or Activities.” The MRCT Center applauds OCR’s considerations of the rights of people with disabilities and OCR’s effort to clarify and strengthen Section 504 of the Rehabilitation Act of 1973. The MRCT Center endorsed several key areas in the proposed rule Center presented some suggestions for further clarification. 

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

October 2023 Newsletter

In the Spotlight

Register for the 2023 Annual Meeting

Join us December 13 – 14 in Boston for our 2023 Annual Meeting! The MRCT Center welcomes you to engage in dynamic and stimulating discussions and presentations of our programmatic work. This year, we are enhancing the meeting to a two-day program featuring a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA); several panel discussions related to our ongoing work; a Research, Development, & Regulatory Roundtable (R3) focusing on (1) privacy laws and (2) data integrity; and a Bioethics Collaborative (BC) forum, discussing ethical issues in gene therapy, all open to registrants at no cost.

Click here for a detailed agenda, the FAQ, and to register. While in-person attendance is encouraged, virtual participation is welcome.

Schedule highlights, in addition to programmatic updates and discussions about MRCT Center work:

  • Panel 1: Post-trial Responsibilities: Continued Access to Investigational Products
  • Panel 2: International Framework for Specimen Sharing: the Seattle Principles
  • Panel 3: Diversity Action Plans and their impact and interpretation through an international and domestic lens
  • Research, Development, and Regulatory Roundtable (R3): 1) Update to the GDPR, including discussion of the EU/US data privacy framework; 2) Considerations for Ensuring Accurate Clinical Trials Data
  • Bioethics Collaborative (BC): Gene Therapy: Probing the Ethics

Joint Task Force for Clinical Trial Competency (JTF) Biannual Meeting: November 14
 
The Biannual Global JTF meeting is scheduled for November 14 from 9:00 – 11:00 AM EST. The virtual meeting will include a progress report on the update of the data management and informatics domain, potential amendments to the JTF Framework to accommodate emergency preparedness competencies, utilization of the JTF Framework for workforce development for clinical research, and experience of using the JTF Framework in Canada and Switzerland. There will also be a time for open discussion with meeting participants.
 
Click here to register.

JTF Framework: Available in Korean

We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Korean. We thank our colleagues and SC sponsors, the Comprehensive and Integrative Medicine Institute (CIMI) and Daegu Catholic University Medical Center for their efforts.

Other available translations: English, Spanish, French, Japanese, Thai, Bahasa Indonesia, Italian, Chinese and Vietnamese. 

Click here to learn about the JTF Framework: Domains and Leveled Core Competencies.

Dr. Bierer in Brazil

MRCT Center Faculty Director Barbara Bierer, MD, traveled to Brasilia, Brazil, to participate in a regional workshop organized by the Pan American Health Organization (PAHO). Key regulatory authorities, research ethics leadership, industry, CROs, and investigators from different countries of the Region of the Americas met to identify, discuss, and propose concrete actions to strengthen scientifically and ethically sound clinical trials in the region. In addition, the meeting helped to inform the 75th World Health Assembly resolution WHA 75.8.

Health Literacy Month Spotlight

Thinking about Numeracy

When crafting patient-facing materials, focusing on health literacy best practices such as plain language, intuitive design, cultural awareness, and usability testing are expected. Numeracy and the clear presentation of numeric data demand additional attention.

In clinical research, understanding risk, percentages, probabilities …

[Continue reading]

Data Literacy: Leveraging PHUSE Videos to Advance Understanding

Participants’ understanding of how their data are collected and used in research is important for empowering value-concordant decision-making. The MRCT Center is actively focused on developing educational materials for the public to understand the concept, importance, use of, and protections for data in clinical trials to complement the exemplary PHUSE Global Healthcare Data Science Community video series on data privacy and data-sharing. This work expands our ongoing commitment to improve health literacy. We welcome additional collaborators to the data literacy initiative. 

Health Literacy On-Demand Webinar: Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials

A recent health literacy webinar focused on best practice strategies to incorporate patient perspectives in crafting participant-facing materials that are accessible, culturally competent, and easy to understand.

Click here to view the webinar resources, including the recording, slides, and related materials.

Events & Presentations

November 3: Dr. Bierer will discuss “Ethical Review of Decentralized Clinical Trials” at the two-day “Human Research Protection: Unstoppable” conference hosted by Cincinnati Children’s, the University of Kentucky (UK), University of Cincinnati (UC), and Northern Kentucky University (NKU).

November 6: The third Diversity Convergence Meeting will take place on November 6, during the Future of Health Summit: November 6-8. This invite-only meeting is expected to be policy-oriented and follows upon the first meeting hosted by CTTI in June and the second meeting hosted by the MRCT Center in September. FasterCures, a center of the Milken Institute, will host the third meeting, send invitations, and provide further communication.

November 6: Dr. Bierer will speak on “Health Equity Convergence across the Biomedical Research Ecosystem” at a Roundtable Discussion during the Future of Health Summit: November 6-8.

November 9 – 11: Dr. Bierer will attend the CIMI conference in Daegu, Korea, presenting on “Scaling Decentralized and Hybrid Clinical Trials to Decrease Participant Burden: Opportunities and Limitations.”

November 13: Dr. Bierer is presenting on “Ethical challenges in clinical research during a pandemic”at the2023 NIH-sponsored Advanced Training Course entitled, “Frontiers in Emerging, Re-Emerging, and Zoonotic Diseases and Diversity (FrERZD2)” at the Ponce Health Sciences University, Ponce, PR.

November 13, 1:30 – 4 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070. Open to R3 Sponsors.

November 16: Dr. Bierer is presenting on “CREDIT and incentivizing the academic culture” at the Vivli Annual Meeting, “Shaping the next 10 years in Data Sharing: Building on the gains made in the past 10 years in advancing human health and looking ahead to the next 10 years,” to be held at NASEM in Washington DC.

November 14: Dr. Carolyn Chapman will be presenting on “Protection of human research participants” at the American Association for Cancer Research (AACR) Translational Cancer Research for Basic Scientists Workshop.

November 17: Dr. Bierer is presenting on the “Role of IRBs in improving the inclusion of sex and gender as variables in clinical research” at the “Sex and Gender Reporting in Musculoskeletal Research Symposium” organized by the Journal of Bone and Joint Surgery and Dr. Kim Templeton, KUMC, and held in Boston, MA.

November 29: Dr. DeCormier Plosky will be participating on a panel, “Approaches to Support the Inclusion and Clinical Study Participation of Individuals with Disabilities Including Intellectual or Developmental Disabilities,” as part of the FDA/CTTI Public Workshop to Enhance Clinical Study Diversity that will be held virtually November 29-30. 

November 30: Dr. Bierer will participate on the panel, “Post-Approval Dissemination of Clinical Study Enrollment Demographic Data to the Public” at the same virtual FDA/CTTI Public Workshop to Enhance Clinical Study Diversity meeting.

December 4 – 6: The MRCT Center at the PRIM&R Annual Conference:

December 4:

  • Dr. Bierer: “What Keeps You Up at Night: Future Frontiers in Research”; “IRB Review of Technology Used for Virtual and Virtual/Remote Clinical Trials”
  • Sylvia Baedorf Kassis: “Supporting Informed Decision Making: How to Foster the Development of Understandable Research-Related Information”
  • Elisa Koppelman: “Including Young People in Research: A Toolkit to Support the Intentional Inclusion of Youth Perspectives in Pediatric Clinical Trials & Product Development” 

December 5:

  • Dr. DeCormier Plosky: “It’s About Time: Inclusion of Sexual and Gender Minorities in Clinical Research”; “Accessibility by Design: Operationalizing Full Commitment to the Americans with Disabilities Act in Clinical Research Practice”

December 6:

  • Dr. Bierer: “Utilizing a System of IRB Precedent: Moving Toward Consistency and Transparency”

December 13 – 14: The MRCT Center Annual Meeting, including meetings of the Research, Development, and Regulatory Roundtable (R3) and Bioethics Collaborative (BC). Open to all registrants at no cost. (See Spotlight above; click here for more information and to register.)

Publications

September 30: The MRCT Center submitted comments in response to the NIH Request for Information (RFI): Inviting Comments and Suggestions on Updating the NIH Mission Statement (NOT-OD-23-163). We wish to commend the NIH for recognizing people with disabilities as a population with health disparities. We also fully endorse the proposed changes to the NIH mission statement and the elimination of the reference to “reduc[ing] illness and disability,” a statement that is ableist and discriminatory. The proposed mission statement is a welcome alignment with the vision and purpose of the agency.  
 
October 1: Barbara Bierer, Deborah Zarin, and Luke Gelinas published “Deprioritization of Ongoing Clinical Trials” to describe the importance of, ethical imperative in, and approaches for ensuring that clinical trials continue to be scientifically relevant and of value once initiated. Published in Ethics and Human Research, they suggested a framework to monitor ongoing trials through periodic review and potential actions for responding to that review.

MRCT Center News

Mansfield Scholars: In late September, the MRCT Center met with The Mansfield-PhRMA Research Scholars Program. This scholarship program is a U.S.-Japan exchange that brings young researchers from Japan’s pharmaceutical and development field to the United States each year. Through these meetings, the researchers learn how government agencies, universities, and pharmaceutical companies collaborate to bring laboratory discoveries to the market. The program helps researchers broaden their view and understanding of U.S. healthcare policy, regulation, and pharmaceutical research and development, as well as gain first-hand insights into how the U.S. ecosystem functions to promote translational research. 

Visitors from the Philippines: Visiting from the Philippines, Marimel Pagcatipunan (middle) visited the MRCT Center earlier this month. Dr. Pagcatipunan successfully completed MRCT Center’s virtual training on Data Monitoring Committees last year. She has since participated in or led multiple DMC committees for trials conducted in Southeast Asia.  

MRCT Center Updates

Carolyn Riley Chapman, PhD, MS, joined the MRCT Center in October 2023. She is a Member of the Faculty of the Department of Medicine at Harvard Medical School and Lead Investigator in the Division of Global Health Equity (DGHE), Department of Medicine, Brigham and Women’s Hospital. Carolyn’s work involves collaboration with diverse stakeholders to identify and address challenges in the research and development of precision medicine, including cell and gene therapies. 

Chloe de Campos joined the MRCT Center as a Student Researcher, Creative Design, during the fall of 2023. In this role, she maintains the digital asset library and Center’s image style guides. In addition, Chloe contributes to the design of both print and digital communication materials for the MRCT Center. 

Chloe enrolled at Brown University in the Fall of 2019 and looks forward to completing her Computer Science degree in May 2023.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

September 2023 Newsletter

In the Spotlight

Announcing the 2023 MRCT Center Annual Meeting: December 13 – 14

Join us December 13 – 14 in Boston for our 2023 Annual Meeting! The MRCT Center welcomes you to engage in dynamic and stimulating discussions and presentations of our programmatic work. This year, we are enhancing the meeting to a two-day program featuring a keynote address from Peter Arlett, Head of Data Analytics and Methods at the European Medicines Agency (EMA), several panel discussions related to our ongoing work, and Research, Development, & Regulatory Roundtable (R3) and Bioethics Collaborative (BC) forums, all open to registrants at no cost.

Click here for more information and to register. While in-person attendance is encouraged, virtual participation is welcome.

Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials
 
As we celebrate Health Literacy Month, we invite you to join us on October 23 from 12-1 PM ET to explore actionable strategies to incorporate participant perspectives to craft patient-facing materials that are accessible, culturally competent, and easy to understand — the key tenets of health literacy. This approach enhances engagement, empowers patients, improves communication, and addresses knowledge gaps, paving the way for improved health outcomes and enriched participant experiences.
 
Click here to register.

IRB Review of Decentralized Clinical Trials (DCTs): Expert Perspectives

Join MRCT Faculty Director Barbara Bierer, Medable’s Leanne Madre, and Advarra’s Luke Gelinas on October 24 from 1 – 2 PM ET for a webinar addressing the ethical, regulatory, and legal challenges that hinder the wider adoption of decentralized clinical trials (DCTs). During this session, participants will explore the distinctions between DCTs and traditional trials, learn effective strategies to enhance participant engagement with DCT tools and methodologies, and gain insights into the ethical review of DCTs. This work reflects the ongoing collaboration between the MRCT Center and Medable, who released the guidance entitled IRB/EC Considerations for DCT Review in June.

Click here to register. 

(left to right): Willyanne Decormier Plosky, Barbara Bierer, Kristin Bartlett, Samjhana Boghati and Hayat Ahmed

Diversity Convergence

The MRCT Center recently hosted an invitation-only Diversity Convergence Project meeting in Washington, DC. The Diversity Convergence Project, a collaborative effort of the Clinical Trials Transformation Initiative (CTTI), FasterCures, the MRCT Center, and the National Academies of Sciences, Engineering, and Medicine (NASEM), seeks to catalyze system-level changes to achieve racial and ethnic diversity in U.S. interventional clinical trials. To fully harness the potential impact and scalability, aligning goals collaboratively with colleagues across the enterprise is essential. This endeavor prioritizes areas that necessitate collective action to transform clinical trials and focuses on eight key domains (see image).

The dynamic day-long symposium featured robust conversations to define action steps for each of the eight domains to support a collaborative suite of deliverables in 2024. FasterCures will host the third meeting of an expanded group in November 2023 to continue to progress the initiative.

Returning Individual Research Results & Data: Digging Deeper webinar series

The MRCT Center released a series of case studies describing stakeholder experiences of returning individual results to participants. The case studies were discussed at a webinar in May.  Given the interest and number of questions we received, we offered three virtual “Digging Deeper” sessions to foster additional discussion about topics that can be challenging to navigate. 

The series explored Pfizer’s Participant Data Return Solution, a discussion by Yale leadership on IRB/HRPP Responsibilities, and a dialogue with NCI on Genetic Testing and Secondary Findings. Click here for resources from these webinars, including the recordings, slides, and related materials.

A Global Plain-Language Standard: MRCT Center Glossary Public Review

The MRCT Center continues to lead the co-creation of a plain-language clinical glossary. As a new CDISC global standard, the MRCT Center Clinical Research Glossary is being developed by a workgroup of dedicated volunteers, including patients, advocates, research professionals, medical writers, and others, to deliver understandable and valuable research information to a broad audience. As part of the process, a CDISC public review period is currently open for seven new words and definitions.

Here is the link to the public review package. We have included a helpful video to guide you through submitting a review.

Please click here for more information about the MRCT Center glossary and our collaboration with CDISC to create a plain-language global standard.

Building Resources to Support the Inclusion of LGBTQIA+ Participants in Clinical Research

The Human Rights Campaign has declared a state of emergency for LGBTQ+ Americans and has reported that “more than 75 anti-LGBTQ+ bills have been signed into law this year alone, more than doubling last year’s number.”   

To support the focus on LGBTQIA+ inclusion, the MRCT Center has been conducting listening sessions to learn more from diverse clinical research stakeholders about potential areas for action to support greater inclusion of sexual and gender-diverse (SGD) people in clinical research. While the existing portfolio of MRCT Center DEI resources (e.g., Achieving Diversity, Inclusion, and Equity in Clinical Research Guidance Document, IRB/HRPP DEI Toolkit, Inclusion of People with Disabilities in Clinical Research) has been widely used to reduce common barriers to trial participation, we are continuing to develop tailored resources where there are population-specific barriers to clinical research participation. 

Respondents in the LGBTQIA+ listening sessions focused on welcoming spaces, imagery, language, data collection (when and how), privacy and safety, site feasibility, and the challenges of multi-site and decentralized trials conducted in disparate environments. We are working on drafting tools to aid sponsors, sites, researchers, and IRBs/HRPPs in fostering greater inclusion and safety of the LGBTQIA+ community in clinical research.

If you would like to share relevant resources or insights, please contact us here. 

Events & Presentations

October 4-5: Dr. Bierer will participate and present at a two-day in-person Regional Workshop co-sponsored by the Pan American Health Organization/World Health Organization (PAHO/WHO) and the Department of Evidence and Intelligence for Action in Health (EIH). Held in Brasilia, Brazil, the meeting will address strengthening clinical trials to provide high-quality evidence on health interventions and improve research quality and coordination.

October 10, 1:00 PM – 3:30 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: The Chat is out of the Bag: The future of AI in Clinical Research. Open to BC Sponsors.

October 23, 12 – 1 PM ET: Amplifying Participant Voices: Crafting Respectful, Inclusive, and Understandable Patient Materials (see Spotlight above). Click here to register.

October 24, 1 – 2 PM ET: IRB Review of Decentralized Clinical Trials (DCTs): Expert Perspectives (see Spotlight above). Click here to register.

November 13, 1:30 – 4 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topic: Recent Regulatory Developments Affecting Clinical Trials in the EU and UK: EU In Vitro Diagnostics Medical Devices Regulation, EU Clinical Trials Regulation, and EMA Policy 0070. Open to R3 Sponsors.

Publications

August 30: MRCT Center Senior Advisor Luke Gelinas co-authored an article with Barbara Bierer and others, “Acknowledging Complexity and Reimagining IRBs: A Reply to Discussions of the Protection-Inclusion Dilemma” in the American Journal of Bioethics. The article responds to the commentary of a prior publication to recognize the nuanced responses to vulnerabilities that too often limit the enrollment of underserved and underrepresented populations.
 
September 5: The MRCT Center submitted comments in response to the FDA/ICH E6(R3) Guideline for Good Clinical Practice; International Council for Harmonisation; Draft Guideline for Industry (FDA-2023-D-1955-0002). The MRCT Center applauds the overall structural redesign of the E6(R3) GCP guideline and enthusiastically supports the proposed changes. Our comments identified specific areas that we believe, with revision and improvement, will further protect the rights, safety, and well-being of all trial participants. 
 
September 5: Mark Barnes, co-faculty director of the MRCT Center and Partner at Ropes & Gray, colleagues Minal Caron and Sarah Dohan at Ropes & Gray, and Barbara Bierer addressed the definition of “recklessness” in research misconduct proceedings, reviewing its history and application and proposing a framework and factors to consider in recklessness determinations. The work was published in Accountability in Research, available here. 

MRCT Center Updates

Daniel Albert-Rozenberg joined the MRCT Center as a Legal Research Assistant in the fall of 2023, focusing on the legal treatment of clinical trial compensation in state and federal benefits calculations. Daniel is currently pursuing his Juris Doctor degree at Harvard Law School. 

Jack Ferdman, JD, MPH, joined the MRCT Center in September 2023 as a Research Analyst, focusing primarily on building a framework(s) for clinical research in times of emergency. Jack will also engage in global clinical trial policy analysis and commentary.

Jack brings 15 years of experience in drug and vaccine discovery research to complement his health policy background. Previously, he worked for AbbVie, Seqirus, and Massachusetts General Hospital, among others, and has contributed to health equity efforts with the White House Office of National Drug Control Policy. 

New Sponsorship

The MRCT Center welcomes ICON as a new Executive Committee sponsor. ICON is a clinical research organization with a mission to help clients accelerate the development of drugs and devices that save lives and improve quality of life. 

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

August 2023 Newsletter

In the Spotlight

Returning Individual Research Results and Data: Digging Deeper Webinar Series

Please join us for the final session of our three-part summer webinar series about the specific ethical, operational, and technical challenges to returning individual research results and data on Thursday, September 21, from 12 – 1 PM.

Based on this case study, the webinar will feature a moderated discussion with Megan Frone from the National Cancer Institute about considerations when returning genetic/genomic results.

Click here to register.

Two earlier webinars in this series explored Pfizer’s Patient Data Return Solution and IRB/HRPP responsibilities. 

Diversity Convergence Project

Racial and ethnic minorities comprise a significant portion of the U.S. population, yet their representation in clinical trials remains disproportionately low. Addressing this disparity is crucial for equitable healthcare outcomes. The Diversity Convergence Project, initiated by the Clinical Trials Transformation Initiative (CTTI), FasterCures, the Multi-Regional Clinical Trials Center of the Brigham and Women’s Hospital and Harvard (MRCT Center), and the National Academies of Sciences Engineering and Medicine (NASEM), seeks to catalyze system-level changes to achieve racial and ethnic diversity in U.S. interventional clinical trials. To fully harness the potential impact and scalability, aligning goals collaboratively with colleagues across the enterprise is essential.
 
The MRCT will host a meeting on September 22 (invitation only) as part of a series of meetings to drive collaborative actions over the next year. This endeavor prioritizes areas that can truly transform clinical trials, necessitating collective action. The project focuses on eight key domains:

*Public Awareness
*Community Investment
*Community Engagement
*Workforce Diversity
*Site Enablement
*Comprehensive Data Utilization
*Funding, Finances, and Support
*Access and Inclusive Participation

Please stay tuned for forthcoming updates regarding this initiative.

JTF Framework: Chinese Translation

We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Chinese.

Other available translations: English, Spanish, French, Japanese, Thai, Bahasa Indonesia, Italian and Vietnamese. 

Thank you to the School of Public Health: Capital Medical University, Beijing Tiatan Hospital: Capital Medical University, and Xunyuan for their effort and commitment to creating this translation.

Register for the Joint Task Force for Clinical Trial Competency Biannual Meeting

The next JTF biannual global meeting has been scheduled for November 14, 2023. Please register here to learn about or present updates and coordinate ongoing activities. 

COVID-19 “Should I Join …?” Flyers now in Urdu

The MRCT Center and Harvard Catalyst collaborated in 2020 on a series of clinical research handouts with general information to prepare potential trial participants before recruitment and consent. Several of those brochures have now been translated into Urdu, in addition to English and Spanish.

Thank you to Dr. Farah Asif, Shahtaj Baig, and colleagues at the Shaukat Khanum Memorial Cancer Hospital and Research Centre in Lahore, Pakistan, for their help in adapting and translating the text.

Events & Presentations

September 11, 11 AM – 12:30 PM: Dr. Barbara Bierer will participate in the inaugural Stanford Think Tank on Diversity and Health Equity in Clinical Trials.

September 15, 11 AM – 12:30 PM: Dr. Barbara Bierer will present on a panel entitled, “Use of Regulatory Headwinds to Manage Towards Properly Enrolled Clinical Trials, at the 2023 AAADV (Accelerating Anticancer Agent Development and Validation) Workshop. Learn more about the three-day conference, September 13-15, here.

September 19, 10 AM – 12:30 PM ET: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Where are we now with Data Privacy, Export Controls, and Foreign Influence? Open to R3 Sponsors.

September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper Session 3: Genetic Testing (see Spotlight above)

September 22: Diversity Convergence Meeting (see Spotlight above)

September 27: Dr. Bierer will address “Diversity Equity and Inclusion in IRB Review and Oversight” at the HHS OHRP Research Community Forum event co-sponsored with the University of Michigan Human Research Protection Program. The conference, Making a Difference in Human Subjects Research: Empowering Participants, Engaging Communities, and Protecting Data, takes place September 26-27, 2023 as an in-person event. Learn more here.

October 4-5: Dr. Bierer will participate and present at a two-day in-person Regional Workshop, co-sponsored by the Pan American Health Organization/World Health Organization (PAHO/WHO), and the Department of Evidence and Intelligence for Action in Health (EIH). The meeting, to be held in Brasilia, Brazil, will address strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination.

October 10, 1:00 PM – 3:30 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: The Chat is out of the Bag: The future of AI in Clinical Research. Open to BC Sponsors.

Publications

July 14: MRCT Center Senior Advisor Luke Gelinas, former MRCT Center Project Manager Walker Morrell, and Faculty Director Dr. Barbara Bierer published an ethical analysis of terms of service and other agreements used in mobile health technologies in clinical research. Risks, mitigating strategies, and recommendations for disclosure (with points to consider) were discussed to help ensure participants’ privacy interests and rights. The article “Terms and Conditions Apply: An Ethical Analysis of Mobile Health User Agreements in Research” was published in the Journal of Law and Biosciences.


July 29: Colleagues in the UK, led by Annabelle South and assisted by Dr. Barbara Bierer, assessed site staff experience in returning plain language summaries to participants after trial completion. Not only did the staff feel that the communication was important, but there were no concerns or challenges in responding to participant questions. Operations and cost were both feasible. The resulting article, “Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomized, factorial, mixed-methods trial,” was published in Clinical Trials.


July 31: The MRCT Center offered comprehensive comments in response to the FDA Draft Guidance FDA-2022-D-2870, entitled Decentralized Clinical Trials for Drugs, Biological Products, and Devices: Draft Guidance for Industry, Investigators, and Other Stakeholders (FDA-2022-D-2870). The MRCT Center applauds the FDA for providing this timely and informative guidance, and our comments are intended to clarify further and expand the Agency’s recommendations. 
 
August 9: As an outgrowth of an international workshop held in Dec 2022, Dr. Bierer collaborated with experts in multiple sclerosis to develop recommendations regarding diversity and inclusivity of participants in clinical trials investigating multiple sclerosis. Their recommendations, “Enhancing diversity of clinical trial populations in multiple sclerosis,” were published in the Multiple Sclerosis Journal.  
 
August 11: Former MRCT Center Project Manager Laura Meloney, MRCT Center Project Manager Hayat Ahmed, and Dr. Barbara Bierer coordinated a modified Delphi process to establish consensus on recommendations for IRBs/ethics committees and institutions to promote diversity and inclusion in interventional clinical research. In this paper, they discuss the 25 consolidated recommendations across four themes. The article, “Review of diversity, equity, and inclusion by ethics committees: a Delphi consensus statement,” was published in Med (CellPress).
 
August 29: Dr. Barbara Bierer co-authored a commentary, “The Unresolved Challenge of Triage,” exploring the ethical and legal challenges of allocating limited care resources in a disaster setting in JAMA.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

July 2023 Newsletter

In the Spotlight

Returning Individual Research Results and Data: Digging Deeper Webinar Series

The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning about topics that can be challenging to navigate. 

The recording, slides, and related materials from the first webinar, Pfizer’s Participant Data Return Solution, held on July 27, will be posted to our website in August. 

Please join us for the two remaining sessions by registering below. 

Session 2: IRB and HRPP Responsibilities 

Thursday, August 17, 12 – 1:00 PM ET: Linda Coleman and Madelon Baranoski of Yale University will discuss a case about returning non-validated test results.

Session 3: Genetic Testing 

Thursday, September 21, 12 – 1:00 PM ET: Megan Frone of the National Cancer Institute will discuss a case about returning secondary findings.

Developing a model Diversity Action Plan (DAP) for Trial Sponsors

The Food and Drug Omnibus Reform Act of 2022 (FDORA) implemented new requirements for clinical trial diversity. Sponsors of late-stage drug and device trials must submit “diversity action plans” (DAPs) outlining their diversity goals for enrollment in the clinical study, the rationale behind those goals, and their strategies to achieve them.  Therefore, the MRCT Center is developing a model DAP based on the MRCT Center’s Recruitment Strategy Document Template.
 
We have already identified important themes and considerations that will enhance the effectiveness and impact of these DAPs. To strengthen the completeness and applicability of this initiative, the MRCT Center is actively gathering DAPs from trial sponsors. If you have one or more examples of a DAP template that you would be willing to share, please email hahmed@bwh.harvard.edu. We will anonymize and use only to build the best DAP template we can.

Promoting Global Clinical Research in Children at the iCAN Summit

MRCT Center Program and Team Director Lisa Koppelman participated in an iCAN multi-disciplinary panel on pediatric clinical trials. The annual iCAN Summit is organized by the International Children’s Advisory Network (iCAN), a consortium of Young Persons Advisory Groups (YPAGS) that advocate for children and families in medicine, research, and innovation.

The MRCT Center and iCAN have collaborated closely to inform and center children’s voices in clinical research. iCAN youth participated in the review of the MRCT Center’s informational materials tailored to a pediatric audience interested or involved in clinical research. iCAN produced three videos showcasing the youth perspective on various research and clinical care aspects. These videos premiered in three of the MRCT Center’s five-part webinar series, Advancing International Pediatric Research.

In a delightful full-circle moment at the iCAN Summit, Lisa shared a warm, in-person exchange with Meg, the spotlight feature of a short video sharing the importance of keeping children well informed throughout the trial journey.

Click here to learn more about the MRCT Center’s pediatric work and the Including Young People in Clinical Research Toolkit. 

Events & Presentations

July 27: MRCT Center Program Director Sylvia Baedorf Kassis led a moderated conversation in the first session of a 3-part webinar summer series, Returning Individual Results and Data: Digging Deeper – Pfizer’s Participant Data Return Solution. In August, webinar resources, including the recording, slides, and related materials, will be posted to the MRCT Center website.

August 17: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper

Session 2: IRB and HRPP Responsibilities (see Spotlight above)

September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3) Topic: Research Collaboration with China: Data Privacy and Foreign Influence. Open to R3 Sponsors.

September 21: 12 – 1:00 PM: Returning Individual Research Results and Data: Digging Deeper

Session 3: Genetic Testing (see Spotlight above)

Publications

June 19: MRCT Center Faculty Director Dr. Barbara Bierer and Program Director Sylvia Baedorf Kassis published an article, “Communicating complex numerical information in clinical research,” in Frontiers in Communication, stressing the importance of numeracy as a component of health literacy.

June 30: The MRCT Center submitted public comments to the Institute for Clinical and Economic Review (ICER) regarding proposed changes to the 2023 Value Assessment Framework. Click here to view.
 
July 5: MRCT Center co-Faculty Directors Dr. Barbara Bierer and Mark Barnes submitted public comments on the NIH Updated Policy Guidance for Subaward/Consortium Agreements, recommending that the guidance be updated to provide greater flexibility to institutions as to the types of documentation that foreign sub-recipients may be expected to share with prime awardees. Click here to view.

July 30: The MRCT Center submitted public comments on the proposed revision of the EU general pharmaceuticals legislation. In broad support of merging the Paediatrics Regulation with general pharmaceuticals legislation, our comments urged the European Commission to ensure pediatric medicines development remains an implementation priority to meet the needs of children throughout Europe. To read the full public comment, click here. 

July 2023: The MRCT Center’s work in collaboration with Medable, Inc., on IRB/EC Considerations for DCT Review continues to garner attention in several publications:

·      ACRP
·      CenterWatch
·      PM360
·      PharmaVoice

MRCT Center Updates

The MRCT Center welcomes Erin Chaves, Administrative Coordinator. She contributes to the Center’s successful operations, including financial and administrative tasks, management of events, coordinating calendars, and other administrative duties.

Summer Reading

Developing imagery for the Clinical Research Glossary

This summer, after reviewing over 200 applications, the MRCT Center welcomed student interns Yimeng (Anna) Lyu and Xinyu (Sandra) Ye to work with MRCT Center colleagues to develop graphic design products for Health Literacy, Individual Return of Results, Diversity, Pediatrics, and other Center projects. They have focused on a comprehensive Clinical Research Glossary graphics library to accompany the plain-language definitions. All images will eventually be available for free use under the terms of our Creative Commons license.

“We hear repeatedly from patients and industry professionals how important images are to effective communication and understanding,” said Program Director Sylvia Baedorf Kassis. “We are thrilled to be able to meet this need while providing an educational opportunity for the next generation of science communicators. This effort crystallizes the MRCT Center’s commitment to promoting a holistic approach to clinical research understanding.”

For Sandra, a junior at Vanderbilt University majoring in Cognitive Studies and Communication of Science and Technology, the work has been an opportunity to meld two interests: science communication and graphic design. “It has been an incredible experience being part of the Health Literacy project team and seeing how a glossary can significantly improve health communication. I focus on visualizing common yet complex research concepts for potential clinical trial participants. I am grateful that my passion and ideas are appreciated here. Receiving feedback from my multi-talented colleagues is enlightening, and I look forward to seeing our combined efforts come to fruition.”

MRCT Center Project Manager Kayleigh To has been working closely with the interns. “Just as the plain language definitions go through a rigorous and iterative review process, these images undergo a similar creative development,” she said. “Ideas for the images are brainstormed before multiple drafts are created, each building upon and incorporating feedback and input. Such care and consideration are a hallmark of the work to create the glossary.”

Anna, a Fine Arts major with a concentration in Graphic Design at Tufts University, sees the work as an enriching and challenging opportunity to innovate in the intersection of art and science. “As part of a multidisciplinary team, I bring my expertise in art and design to create brand-aligned visual assets, including illustrations, icons, and a style guide. With user-centered and inclusive design, I aim to craft visuals that simplify complex concepts for diverse audiences. I am proud that our work will enhance health literacy and empower individuals to make informed decisions about their participation in clinical research.”

The MRCT Center’s Clinical Research Glossary currently has 53 plain-language terms. A bank of 118 additional words has recently undergone an extensive public review with CDISC and is slated to be added to the glossary by the end of the year.

Click here to read more about our process of developing a consensus-driven, plain-language clinical research glossary.

Click here to learn more about the MRCT Center’s collaboration with CDISC to make our plain-language clinical research glossary a global standard.

The MRCT Center provides a unique and trusting community to improve the integrity, safety, and rigor of global clinical trials. Join us in our efforts to develop innovative solutions and aligned approaches to global clinical research.

Learn more about becoming an MRCT Center sponsor.

June 2023 Newsletter

In the Spotlight

The MRCT Center and Medable convened a multi-stakeholder group to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). Together, they presented a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices” on June 20.

MRCT Center Faculty Director Dr. Barbara Bierer and Medable’s Dr. Pam Tenaerts and Leanne Madre presented guidance and tools organized around 12 key elements during the webinar. These elements are grouped into three domains: People, Remote Data Collection, and Data Oversight. The aim is to provide IRBs, ethics committees (ECs), and sponsors with a framework, tools, recommendations, and best practices for conducting ethical review. Advarra representative Robert Ramanchuk provided insights into the real-world, practical implications of the recommendations.

For more about the IRB/EC Considerations for DCT Review, click here.

Click here to view the webinar resources, including the recording and presentation slides.

Return of Individual Research Results and Data: Digging Deeper Webinar Series


  
The MRCT Center released a series of case studies describing research stakeholder experiences of returning individual results to participants at a recent webinar. 
 
Given the interest and number of questions we received, we offer three virtual “Digging Deeper” sessions to foster additional discussion and learning related to returning individual results.
 
The series will feature conversations with Pfizer, Yale University, and the National Cancer Institute representatives. Please register for one, two, or all by clicking the links below.
 
Session 1: Pfizer’s Participant Data Return Solution
Thursday, July 27, 12 – 1:00 PM ET: Paula Boyles, Pfizer, Inc
 
Session 2: IRB and HRPP Responsibilities
Thursday, August 17, 12 – 1:00 PM ET: Linda Coleman and Madelon Baranoski, Yale University
 
Session 3: Genetic Testing
Thursday, September 21, 12 – 1:00 PM ET: Megan Frone, National Cancer Institute

Joint Task Force for Clinical Trial Competency (JTF) News

The MRCT Center hosted a biannual global meeting of the Joint Task Force for Clinical Trial Competency (JTF) on May 2. The meeting included updates from various members of the JTF and progress reports from workgroups, including Data Management and Informatics, Assessment, and Emergency Preparedness.

Click here to read the meeting summary.

The next biannual global meeting has been scheduled for November 14, 2023. To learn about or present updates and coordinate ongoing activities, please register here.

A Global Plain-Language Standard: MRCT Center Glossary Public Review

The MRCT Center continues to lead the co-creation of a plain-language clinical glossary. As a new CDISC global standard, the MRCT Center Clinical Research Glossary is being developed by a workgroup of dedicated volunteers, including patients, advocates, research professionals, medical writers, and others, to deliver understandable and valuable research information to a broad audience.

As part of the process, a CDISC public review period is currently open for 118 new words and definitions.

Here is the link to the public review package.

We have included a helpful video to guide you through submitting a review.

Please click here for more information about the MRCT Center glossary and our collaboration with CDISC to create a plain-language global standard.

Pediatric Brochures in Arabic

We are delighted to share that several pediatric educational brochures to explain aspects of clinical research have been translated into Arabic by our colleagues at the King Hussein Cancer Center in Amman, Jordan. We are grateful for this ongoing collaboration.

·     What is Clinical Research?

·     What is Assent?

·     What is Assent to Consent?

·     What happens at the end of a Research Study?

Stay tuned for translations into additional languages! Please contact Lisa Koppelman at ekoppelman@bwh.harvard.edu if you are interested in partnering to translate and adapt these or any of our other pediatrics-focused materials.

Events & Presentations

June 21-22: The MRCT Center leadership hosted External Advisory Board and Executive Committee meetings in Cambridge, MA. These meetings focused on the MRCT Center’s strategic planning and vision of our work, which are critical steps in our efforts to develop innovative solutions and aligned approaches to global clinical research.

June 27 and 28: Faculty Director Dr. Barbara Bierer presented IRB/EC Considerations for Ethical Review and PI Oversight at the DIA conference in Boston.

June 28: Program Director, Sylvia Baedorf Kassis MPH, presented “Returning Individual Participant Data: A Cultural & Operational Shift Towards Personalized Clinical Trial Options” at the DIA conference in Boston.

July 27, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 1: Pfizer’s Participant Data Return Solution (see Spotlight above)

August 17, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 2: IRB and HRPP Responsibilities (see Spotlight above)

September 12, 1:30 – 4:00 PM: Meeting of the Research, Development, and Regulatory Roundtable (R3)

Topic: Research Collaboration with China. Open to R3 Sponsors.

September 21, 12 – 1:00 PM: Returning Individual Returns and Data: Digging Deeper

Session 3: Genetic Testing (see Spotlight above)

Publications

May 25, 2023: MRCT Center Program Director Dr. Deborah Zarin co-authored an article, “Bringing data monitoring committee charters into the sunlight,” in Clinical Trials, addressing the lack of access to data monitoring committees (DMCs) charters and calling on the NIH to allow their voluntary upload into ClinicalTrials.gov.  

June 2023: The MRCT Center’s work on IRB/EC considerations for DCT review with Medable, Inc. was cited in several publications:
·      Biospace
·      Applied Clinical Trials
·      Contract Pharma
·      Trial Site News
·      Clinical Trials Arena
·      Clinical Research News
·      Clinical Trials Arena/INFORMA

Quotable Quote: June 7, 2023: MRCT Center Program Director Sylvia Baedorf Kassis was quoted in an article, “Patient Data Return: Do the Benefits Outweigh the Barriers?” in Applied Clinical Trials Online, speaking about the importance of returning individual results and data to Clinical trial participants.

MRCT Center Updates

The MRCT Center welcomes three new team members:

Alyssa Panton: Research Assistant

Alyssa will be primarily involved in the Center’s clinical research data literacy and AI work and is very interested in global
health ethics, health equity, and human subject protection and education.
 
Alyssa obtained her Master of Bioethics degree from Harvard Medical School and her Bachelor of Arts in the History of Science and Language from Harvard.


Yimeng (Anna) Lyu: Student Researcher, Creative Design

As a summer intern, Anna works on creative design and research for several MRCT Center projects, including the Clinical Research Glossary and Promoting Global Clinical Research in Children.
 
Anna is a senior at Tufts University, School of Museum Fine Arts, pursuing her Bachelor of Fine Arts (BFA) degree.


Xinyu (Sandra) Ye: Student Researcher, Creative Design

As a summer intern, Sandra works on creative design and research for several MRCT Center projects, including the Clinical Research Glossary and Promoting Global Clinical Research in Children.
 
Sandra is a junior at Vanderbilt University pursuing a Bachelor of Science in Cognitive Studies and Communication of Science and Technology.

May 2023 Newsletter

In the Spotlight

Upcoming Webinar: June 20th from 10 – 11 AM ET

Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices

The MRCT Center and Medable convened a multi-stakeholder task force to address ethical and regulatory opportunities and challenges related to Decentralized Clinical Trials (DCTs). We invite you to join us on June 20, from 10 – 11 AM ET, for a joint webinar entitled, “Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources & Best Practices.”

During the webinar, Barbara Bierer (MRCT Center), Pam Tenaerts (Medable) and Leanne Madre (Medable) will present a framework, recommendations, and tools organized around 3 DCT domains: People, Remote Data Collection, and Data Oversight. Best practices for the ethical review, approval, and conduct of DCTs will be provided.

We invite clinical trial stakeholders (IRB/ECs, HRPP, sites, sponsors, investigators, and others) to register for the webinar. Please click here to register.

Accessibility by Design (AbD) Toolkit and Resources
 
The Accessibility by Design (AbD) in Clinical Research Toolkit is now available here. The AbD toolkit was developed with people with disabilities, caregivers, allies, disability rights advocates, and stakeholders in clinical research.  

On May 4th, the MRCT Center held a webinar in which Dr. Willyanne DeCormier Plosky presented the background, structure, and key themes of the AbD Toolkit. Invited speaker Cecile González-Cerimele shared lessons learned as a family caregiver during clinical trials, a leader in the planning and conducting of clinical research, and a member of the EnAble employee resource group at Eli Lilly. Duke Morrow could not attend but shared, via moderator Dr. Barbara Bierer, his lived experience as a person with a disability, trial participant, and [community] IRB member. “Any researcher must put aside any knowledge they have learned academically and accept the lived experience of the participants.” 
 
The MRCT Center welcomes your feedback on the AbD Toolkit. Please send suggestions, additional tools and resources, and concerns to mrct@bwh.harvard.edu. We look forward to continuing to work together with people with disabilities, their allies, study teams, sites, and sponsors to further the inclusion of people with disabilities in clinical research. 

Dr. Bierer at the African Vaccine Regulatory Forum (AVAREF)

Dr. Barbara Bierer attended the semi-annual African Vaccine Regulatory Forum (AVAREF) meeting in Yaoundé, Cameroon, in April. She presented on the MRCT Center’s efforts to build the capacity of, and to develop tools, training, and resources for, ethics committees across Africa. In addition, with AVAREF leadership, she reported on her visits to Kenya and Nigeria to optimize the conduct and timing of interventional clinical trials. 

Return of Individual Research Results and Data: Case Study Resources

On May 2, the MRCT Center hosted the webinar “Returning Individual Research Results and Data to Participants: Experience from the Field.” Over 200 people joined live to hear five leaders from across the clinical trials ecosystem share their experiences supporting participants and designing and implementing institutional procedures to receive individual research results and data.  

Thank you to our panelists and attendees for such an engaging session. Click here for a summary of the webinar Q&A with responses to questions we didn’t have time to address live.  

Click here to view a full webinar recording, download slides, and access the MRCT Center’s Return of Individual Results resources on our dedicated website. 

Additional Translations of the Joint Task Force (JTF) Core Competencies

We are delighted to announce that the Joint Task Force for Clinical Trial Competency (JTF) Core Competency Framework for Clinical Research Professionals is now available in Italian and Vietnamese.  

Other available translations: English, Spanish, French, Japanese, Thai, and Bahasa Indonesia.

The MRCT Center at AAHRPP

Dr. Barbara Bierer and Linda Coleman, JD, Director of the Human Research Protection Program at Yale University, delivered a joint session on the Ethical Review of Decentralized Clinical Trials (DCTs) at the 2023 AAHRPP conference. Challenges in the IRB review of DCTs, as well as institutional HRPP concerns, recommendations, tools, and resources, were discussed at the session. 

Sylvia Baedorf Kassis, Program Director at the MRCT, and Jonathan Miller, Associate Vice President for Research Regulatory Oversight at the University of Alabama at Birmingham, discussed the roles and responsibilities of HRPPs in returning aggregate and individual research results, emphasizing the need for a comprehensive, operational plan for returning results return program throughout the study lifecycle. Key resources were also reviewed to support researcher-participant engagement. 

Hayat Ahmed, Program Manager at the MRCT Center, showcased tools and resources for incorporating diversity, equity, and inclusion (DEI) in IRB/HRPP processes. The 15 tools developed by the MRCT Center in collaboration with task force members were presented. Conference participants awarded Ms. Ahmed the distinguished poster award. 

Events & Presentations

May 10: Dr. Barbara Bierer presented “Diversity, equity, inclusion, and Integrity in clinical trials: towards effective advocacy and action” at the SWOG Cancer Research Network annual meeting.

June 1 from 1:00 – 3:30 PM ET: Research, Development, and Regulatory Roundtable (R3) – open to Sponsors of R3.

Topics: (1) The Revolution in Online Behavioral Advertising – What it Means for the Research Enterprise, (2) Challenges in Decentralized Clinical Trials – Open Discussion Forum

June 20 from 10 – 11 AM ET: Ethical Review of Decentralized Clinical Trials (DCTs): Tools, Resources and Best Practices (see Spotlight above)

Click here to register.

Publications

April 25: Dr. Deborah Zarin co-authored a research letter examining the proportion and timing of results dissemination for registered trials by data source, “Comparison of Availability of Trial Results in ClinicalTrials.gov and PubMed by Data Source and Funder Type,” in JAMA.


April 26: Dr. Barbara Bierer and Sylvia Baedorf Kassis, along with colleagues in the Republic of Korea, China, and the US, co-authored a paper, “Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations,” in International Journal of Clinical Trials, describing the experience of conducting a multinational acupuncture study during the pandemic.


May 8: Dr. Barbara Bierer, Francis Shen, and others published a novel framework specific to the ethical, legal, and social implications of returning individual research results in digital phenotyping research, with specific reference to psychiatry. See “Returning Individual Research Results from Digital Phenotyping in Psychiatry” in the American Journal of Bioethics. 


May 25: Dr. Willyanne DeCormier Plosky and Barbara Bierer published “New Tools to Support Inclusion of People with Disabilities in Clinical Research,” based on the recently released Accessibility by Design (AbD) Toolkit, in Amp&rsand, the PRIM&R blog.