News Type: Newsletter

In the Spotlight

Join Us for the MRCT Center’s Annual Symposium in Boston!

Mark your calendar for November 13-15, 2024, to attend a compelling three-day symposium featuring dynamic presentations and discussions. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.

Wednesday, November 13 – open to EC/SC sponsors: The day will begin with a meeting with the Post-Trial Responsibilities – Continued Access to Investigational Products working group, followed by lunch and the EC/SC meeting.

Thursday, November 14 – open to the public at no charge:

The day will feature a keynote address by Dr. Khair ElZarrad, Director of the Office of Medical Policy at the FDA, as well as presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. Panel discussions will include AI – Synthetic Data and Digital Twins; Post-trial, Continued Access to Investigational Medicines and Devices; and Impacts of Revisions to the Declaration of Helsinki.

Friday, November 15 – open to the public at no charge: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).

Click the link below to learn more about the agenda and to register for some or all events.

Mansfield-PhRMA Research Scholars at MRCT Center

On September 16, eight scientists and clinical researchers from hospitals and universities across Japan, three government officials from PMDA, AMED, and METI, and three staff members from the Maureen and Mike Mansfield Foundation in Washington, DC, visited the MRCT Center. Sarah White presented about the work of the MRCT Center, and Rebecca Li presented about Vivli and engaged in discussions with the scholars.

Events & Presentations

September 23: Carolyn Chapman served on a panel on Community Engagement and Accessibility at the Rosamund Stone Zander Translational Neuroscience Center (RSZ TNC) at Boston Children’s Hospital’s fifth research symposium entitled Paving the Path: Therapeutic Development Readiness for Rare Neurogenetic Disorders.

September 29-30: Sylvia Baedorf Kassis spoke at the Society for Clinical Data Management (SCDM) conference in Boston. On Sunday, September 29, she presented at the SCDM Leadership Forum, discussing how industry leaders can collaborate to simplify the clinical trial journey for patients and sites. On Monday, September 30, she participated in a panel focused on incorporating site and patient voices in decentralizing clinical trial activities. For both sessions, she was joined by Marilyn Neault, PhD, a Patient Advocate for Research and long-time co-leader of the MRCT Center Clinical Research Glossary workgroup.

October 8: Carolyn Chapman will present on the “Protection of Human Research Participants” at the American Association for Cancer Research (AACR)’s workshop on Translational Cancer Research for Basic Scientists.

October 8, 12:00 pm ET: Willyanne DeCormier Plosky will present with Zary Amirhosseini (Program Manager, MGH Disability Program), Martha Jones (Vice President, MGB Human Research Affairs), and Jeanhee Chung (Principal Investigator, MGH Lab of Computer Science; Instructor in Medicine, Harvard Medical School) on “Empowering Voices: Strategies for Involving Individuals with Disabilities in Research.” This webinar is part of the Chester Pierce Research Society Speaker Series.

October 8: Hayat Ahmed will participate in a Clinical Trial Diversity Roundtable hosted by Congresswoman Robin Kelly (IL), Chairwoman of the Congressional Black Caucus (CBC) Health Braintrust, at the La Rabida Children’s Hospital in Chicago.

October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Session 1: Designing Impactful Informed Consent Processes that Empower Participants 

October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Tests, and 2) Limitations on Sharing Data with China and Other Countries of Concern

October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.

October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”

October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience

October 21, 11:00 am ET: Willyanne DeCormier Plosky will present at Penn State College of Medicine/ Penn State Clinical & Translational Science Institute on “Mapping the Participant Journey: Disability Inclusion in the Research Process.”

October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

Oct 31-Nov 1: Willyanne DeCormier Plosky will deliver a keynote speech at the University of Monterrey (Mexico) 2nd International Symposium on Medical Education. The keynote title is “Gender Perspectives and Inclusion: Key Elements in Transforming Medical Education for a Future of Personalized and Safe Care.”

Nov 13 – 15: MRCT Center Annual Symposium. Click here to learn more about the agenda and to register.

November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA). Click here to register for this event solely or for all MRCT Center Annual Symposium events.

The MRCT Center at PRIM&R Annual Conference:

• November 18, 12:30 – 1:30 pm PT: Barbara Bierer and REACH Collaborative colleagues Michelle Feige (AAHRPP), Ivy Tillman (PRIM&R), Martha Jones (Mass General Brigham) will present “REACH: the Research Ethics Collaborative for HRPPs for Justice.”
• November 18, 1:45 – 3:00 pm PT: Barbara Bierer and Benjamin Silverman (Mass General Brigham) will present “Accessing Capacity to Consent for Research Participation: When and How Do You Actually Do It?”
• November 19, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will join Sarah Muenster-Blakeley (University of St. Thomas) and Cecilia Brooke Cholka (Weill Cornell Medicine) to present “Accessibility Basics: Making Word Documents and Videos Accessible.”
• November 19: 1:45 – 3:00 pm PT: Barbara Bierer and Adam Berger (NIH) will present “Building Trust in Science: Enabling Frameworks for Returning Individual Research Results to Research Participants.”
• November 19, 1:45 – 3:00 pm PT: Willyanne DeCormier Plosky will be presenting with Christina Dragon (GMRO, NIH), Amy Ben-Arieh (The Fenway Institute), and Keith Dawson (Genentech) at a plenary session titled “(E01) Fast Forward: Update on Inclusion of Sexual and Gender Minorities in Clinical Research.”
• November 20, 10:30 – 11:45 am PT: Willyanne DeCormier Plosky will moderate a panel titled “(H07) Protecting Third Parties in Research: Whose Job Is it Anyway?” The panel will feature Iris Jenkins (Virginia Tech) and Marilyn Lamm (Clinical Biosafety Services) as speakers.

December 10, 9 – 11 am ET: Biannual Global Meeting of the Joint Task Force for Clinical Trial Competency. This virtual meeting is open to all registrants.

December 12: Meeting of the Bioethics Collaborative.

Publications

August 30: The MRCT Center recently submitted comments to the National Library of Medicine (NLM) in response to the “Evolving the Network of the National Library of Medicine” initiative (NOT-LM-24-001), emphasizing the importance of enhancing health literacy through better access to clinical research information. Key recommendations included expanding MedlinePlus to include more content related to clinical trials, integrating plain language definitions into ClinicalTrials.gov, and providing aggregate study results in plain language for participants. The MRCT Center also suggested improvements to ClinicalTrials.gov that would allow current participants to access updates on study progress and individual results and harmonize study-specific data elements to facilitate cross-study comparisons. These recommendations aim to improve public engagement, transparency, and trust in the clinical research ecosystem.

September 25: The MRCT Center commented on the FDA Draft Guidance on Diversity Action Plans (DAPs) to improve Enrollment of Participants from Underrepresented populations in Clinical Studies (ID FDA-2021-D-0789-0111). The MRCT Center comments point to the need for greater transparency on the timing of FDA feedback and the criteria the FDA uses to assess the community engagement, site selection, recruitment, enrollment, and retention plans in DAPs (both for domestic and global trials). We also recommend clarifying whether DAPs are required for Phase 3 trials for both new and previously approved products, how to operationalize a “do no harm” approach in enrollment goals (that may involve global trial participants), and when it may be appropriate to disaggregate US enrollment goals/data from global enrollment goals/data. The comments suggest a framework similar to the April 2022 draft to improve the final guidance, starting with an epidemiological overview and guiding organizations in developing effective diversity strategies.

MRCT Center Updates

Ava Glazier, a student researcher at the MRCT Center since 2019, was recently promoted to Research Assistant.

Ava is involved in projects focused on Diversity, Inclusion, and Equity in Clinical Research, Cell and Gene Therapy, and Reproductive Health. Previously, she worked on initiatives related to pediatric populations in clinical trials, health literacy, and informed consent forms. In addition to her work at the MRCT Center, Ava has interned at Takeda Pharmaceuticals in the Health Equity Department and at FTI Consulting, where she contributed to efforts to increase patient access in large hospital systems. She is passionate about improving maternal health outcomes in underserved populations and advancing policies to enhance the healthcare experience for patients and providers.

Ava graduated from Brown University with a Bachelor of Arts in Public Health in May 2024. She is pursuing a Master of Public Health focusing on health policy at the Brown University School of Public Health.

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.

In the Spotlight

Join Us for the MRCT Center’s Annual Symposium in Boston!

Mark your calendar for mid-November to attend a dynamic three-day symposium featuring presentations and discussions with thought leaders and research stakeholders. The first day is open to Executive and Steering Committee (EC/SC) sponsors. The annual two-day event that follows is open to all registrants at no cost. While we encourage in-person attendance, virtual participation is welcome.

Wednesday, November 13: The day will begin with a meeting with the Post-trial, Continued Access to Investigational Medicines in Lower and Middle-Income Countries working group, followed by lunch and the EC/SC meeting.

Thursday, November 14: The day will kick off with a keynote address (TBA) and continue with presentations on the MRCT Center’s recent and upcoming work, breakout sessions, and a cocktail reception. A more detailed agenda will be released in our September newsletter.

Friday, November 15: Vivli, the Center for Global Clinical Research Data, in conjunction with the MRCT Center, will host “Innovations in Data Sharing,” a half-day program featuring Dr. Steffen Thirstrup from the European Medicines Agency (EMA).

A link to the registration will be emailed separately in the next two weeks.

The Joint Task Force for Clinical Trial Competency (JTF), anchored at the MRCT Center, is dedicated to developing and disseminating standards and practices for the clinical research workforce. The JTF fosters a cohesive, global approach to ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically.

Updates: The meeting summary and slides from the June JTF Biannual Global Meeting Summary,  celebrating the 10^th anniversary of the publication of the JTF Core Competency Framework, are now available. 

The JTF Framework has been translated into Portuguese, and is the twelfth translation now available. See the complete list here.

Events & Presentations

Left to right: Missy Heidelberg (Takeda Pharmaceuticals), Matt Rotelli (Eli Lilly and Co), Anna Kang (Genentech – a member of the Roche Group), Cris Woolston (Sanofi), Pat Nebel Hill (Genentech – a member of the Roche Group), CeCe Brotchie-Fine (Novartis), Karla Childers (Johnson & Johnson), Diana Pankevich (Pfizer), Barbara Bierer (MRCT Center)

August 15-16: Barbara Bierer attended the North American Regional Meeting on the Declaration of Helsinki (DoH) in Washington, DC, a meeting that was also attended by several MRCT Center Executive Committee and Steering Committee representatives. The meeting was the final discussion of the DoH revision. Dr. Bierer discussed the challenges in determining scientific and social value in clinical trials.  

August 24: Sylvia Baedorf Kassis was a featured speaker at the iCAN Virtual Chapter Meeting, sharing information on the Clinical Research Glossary and ways for young people to get involved.

August 30: Barbara Bierer presented on single IRB review of multi-site, multinational clinical trials at the international meeting entitled, “the U.S. single IRB policy: challenges and lessons,” hosted by the Pan American Health Organization (PAHO) Regional Program on Bioethics and Quality and Regulation of Medicines and Health Technologies Unit.

Upcoming Webinars and Presentations

September 10: Meeting of the Bioethics Collaborative: Impact of Dobbs on Reproductive Health: Unintended Consequences for/on Research.

September 10: Sylvia Baedorf Kassis will present the Clinical Research Glossary at Pfizer’s internal Health Literacy & Patient Activation Community of Practice meeting.

September 29 – 30: Sylvia Baedorf Kassis will present two panels at the Society for Clinical Data Management (SCDM) conference in Boston. 

October 10, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 1: Designing Impactful Informed Consent Processes that Empower Participants

October 10: Meeting of the Research, Development, and Regulatory Roundtable (R3). Topics: 1) Laboratory Developed Tests, and 2) Limitations on Sharing Data with China and Other Countries of Concern

October 10, 8 am – 4:30 pm ET: Dr. Barbara Bierer and Mark Barnes will be featured as panelists at the “Advancing Trust in Science: Institutional Obligations to Promote Research Integrity,” a hybrid event hosted by the Department of Medical Ethics & Health Policy and the Institute for Translational Medicine & Therapeutics: University of Pennsylvania Perelman School of Medicine.

October 15, 12:00 pm ET: Willyanne DeCormier Plosky will present at the SCRS IncluDE Site Summit follow-up webinar titled “IncluDE Encore: Inclusivity Forum for People with Disabilities.”

October 17, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 2: Creating and Sharing Plain Language Summaries: One Team’s Experience

October 22, 12 – 1 pm ET: Health Literacy Month Webinar Series – Session 3: Designing PowerPoint Presentations to Support Health Literacy and Accessibility 

Nov 13 – 15: MRCT Center Annual Symposium. A registration link will be sent separately soon.

November 15, 9 am – 2 pm ET: Vivli Annual Meeting, in conjunction with the MRCT Center: “Innovations in Data Sharing.” Keynote with Dr. Steffen Thirstrup of the European Medical Association (EMA).

Publications

Stephen Sonstein and Barbara Bierer are co-authors of a Frontiers in Pharmacology editorial that introduces the collection of the Research Topic: “Building the Clinical Research Workforce: Challenges, Capacities and Competencies.” Thirteen articles discuss the challenges and opportunities relating to the clinical research workforce and highlight the role and significance of the Joint Task Force for Clinical Trial Competency (JTF) Framework. Frontiers in Pharmacology has also published “Building the Clinical Research Workforce: Challenges, Capacities and Competencies” as an eBook.

Mariana Kruger, Moji Adeyeye, and Barbara Bierer co-authored a book chapter entitled “Pediatric drug development issues during public health emergencies” in the book Essentials of Translational Pediatric Drug Development. In their chapter, the authors outline the regulatory and ethical issues that arise during public health emergencies, focusing on pediatric drug development. 

July 15: The MRCT Center commented on the White House Office of Science and Technology Policy (OSTP) Request for Information entitled “Federal Evidence Agenda on Disability Equity,” published at 89 Fed. Reg. 46924 (May 30, 2024). Read more here

July 22: The MRCT Center commented on the National Institutes of Health (NIH) Office of Science Policy’s draft Intramural Research Program Policy: Promoting Equity Through Access Planning (NOT-OD-24-125). In brief, the MRCT Center recommended that NIH OSP (1) clarify and expand on the methods to promote equitable access, (2) consider greater flexibility in the application of this policy to investigational products, and (3) require direct engagement with community stakeholders and patient advocacy groups when NIH assesses the impact of the policy. Read more here.

August 1: Barbara Bierer authored an article, “The Role of Institutional Review Boards in Improving the Inclusion of Sex and Gender as Variables in Clinical Research,” in the Journal of Bone and Joint Surgery.

August 5: Mark Barnes, colleagues at Ropes & Gray, and Barbara Bierer published “The PubPeer conundrum: Administrative challenges in research misconduct proceedings” in the journal Accountability In Research that analyzed the impact of PubPeer, an online platform that publicizes suspected data integrity concerns, on the research misconduct process and the institutional challenges of handling anonymous comments within current regulations. The authors propose processes to ensure that credible allegations are rigorously assessed while reducing the burden on institutions tasked with their investigation.

August 9: The MRCT Center commented on the NIH Request for Information regarding Strategies for Maximizing Public Engagement in NIH Supported Clinical Research (NOT-OD-24-133). The MRCT Center recommended that NIH encourage researchers and their institutions to establish continuous and bilateral relationships with their communities prior to, during, and after research, budget for those activities, and provide training. Several of our collaborators with meaningful lived experiences, including study participants, patient advocates, and clinical researchers, contributed to the response.  Read more here.

August 19: The MRCT Center commented on the NIH Request for Information regarding its draft Public Access Policy (FR Doc. 2024-13373). We recommended that NIH require plain language summaries for all manuscripts submitted to PubMed Central. We supported NIH’s proposal to eliminate the embargo period for publications while requesting further consideration of the practical implementations of the proposed change, sensitive to the potential increase in costs to manuscript submission and other unintended consequences. Read more here.

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.

In the Spotlight

Accessibility 101: How to Write Alt Text and Map Participant Journeys

Please join the MRCT Center and the Research Ethics Action Collaborative for HRPPs (REACH) for the first webinar in the Accessibility 101 series. People with disabilities are the largest minority population in the United States, yet they are often excluded from clinical trials, both as participants and as researchers. Federal regulations, such as the recently updated Section 504 of the Rehabilitation Act, prohibit discrimination based on disability. Many accommodations are easy and low or no cost. It is incumbent upon all of us to build accessibility into our everyday thinking, meetings, presentations, and planning. This webinar will help advance that goal.

This webinar will feature two interactive exercises in which participants will learn:

• Basic information about disability statistics and disability rights, as shown through the Accessibility by Design in Clinical Research Toolkit, and different types of support that you can readily implement.
• How to find the Check Accessibility and Alt Text features in PowerPoint and write appropriate Alt Text.
• How to map the participant’s (and family caregiver’s or supporter’s) journey from different disability perspectives, from getting to/into the site location, navigating within the site to the different areas they must access, and interacting with different forms of medical equipment and technology.

More Information about REACH:

Research Ethics Action Collaborative for HRPPs (REACH) is 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.

 Click here to learn more.

Publications

May 31: Sylvia Baedorf Kassis and Barbara Bierer contributed to an article, “A Federally Qualified Health Center-led Ethics and Equity Framework & Workflow Checklist: An Invited Commentary in Response to a Relational Public Health Framing of FQHCs during COVID-19” in the Journal of Law, Medicine & Ethics.

COVID-19 illuminated the need for equity-informed practices in public health. This manuscript presents a community-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement between community health centers and the populations they serve.  

June 18: (NOT-OD-24-112). The MRCT Center submitted public comments on a proposed glossary of innovative clinical research terms published jointly by FDA and NIH, “FDA-NIH Terminology for Clinical Research.” We encouraged clarification of the scope and intended audience of the draft glossary and recommended additional terms for inclusion in the final version. The FDA-NIH glossary will complement the MRCT Center’s Clinical Research Glossary efforts.

June 18: Sylvia Baedorf Kassis contributed an article, “An Easy-to-Understand Clinical Research Glossary to Support Participants and Professionals,” to the Association of Clinical Research Professionals (ACRP) Blog.

June 20: Mark Barnes and Barbara Bierer published “Proposed Increases in Government Authority Over Research Misconduct Proceedings” in the American Medical Association’s JAMA Viewpoints.

The article examines a proposed increase in government authority over research misconduct proceedings and notes that academic and medical institutions should understand the public, political, and ethical pressures on the Office of Research Integrity (ORI) to enhance oversight of research integrity. Institutions can alleviate some of these pressures by making their research misconduct processes more exacting, efficient, and, when possible, more transparent regarding the outcomes of specific cases. This can lead to improved public trust in the scientific research enterprise.

June 20:  (FDA–2023–D–5470): FDA continued its guidance series on RWE, issuing “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products.” In support of the guidance, the MRCT Center submitted public comments requesting further development of FDA’s concerns that are unique to RWE-based studies and the cross-referencing of the current guidance to specific sections of other RWE guidance documents to streamline the end-user experience.

June 24: The MRCT Center submitted public comments in response to the World Medical Association’s (WMA’s) second phase of proposed revisions to the Declaration of Helsinki (DoH). Mark Barnes, MRCT Center Faculty Co-Director, attended the last working meeting on the DoH. In direct response to concerns discussed internally and with our Executive and Steering Committees, we recommended substantial revisions to the WMA Workgroup’s proposals, including recommending comments specific to vulnerable populations, research ethics committees, informed consent, and post-trial access. Both Mark Barnes and Barbara Bierer have been invited to attend the final WMA revision discussion meeting in Washington, D.C. this August.

June 24: Sylvia Baedorf Kassis and Barbara E. Bierer were co-authors of a paper published in “Cancer” entitled “Acupuncture for hot flashes in hormone receptor‐positive breast cancer: A pooled analysis of individual patient data from parallel randomized trials.” The MRCT Center helped advise the study teams in the coordination and conduct of multi-national, collaborative research.

June 25: We responded to a series of three FDA draft guidance documents addressing eligibility criteria for U.S.-based cancer clinical trials. For all three documents, we were supportive of the efforts the FDA has taken to make clinical trials more representative of the intended post-approval patient population. We encouraged additional clarity and granularity with regard to operationalizing these draft guidelines, in advance of their final issuance. Further, we agreed that eligibility criteria should be carefully considered, caution against copying and pasting eligibility criteria from the protocol of one study into the draft protocol of a new study, and advocate that exclusion criteria should be clearly justified based on safety or ethical reasons.

(FDA-2024-D-1402) Specific to the first draft guidance of the series, (i) “Cancer Clinical Trial Eligibility Criteria: Laboratory Values,” we stated in our public comment submission that the MRCT Center agrees with the FDA that overly restrictive laboratory value-based eligibility criteria are problematic and that such criteria may well exclude the very cancer patients that may benefit from the treatment under study, particularly when the malignancy (or its prior treatment) is affecting those lab values. The MRCT Center also asked for more specific examples of how to describe the potential variation of lab values (e.g., by race) and any additional/confirmatory testing needed in the eligibility criteria so as to better support a position of inclusion-by-default and exclusion-only-when-necessary.

June 25: (FDA-2024-D-1377). The main takeaway from the public comments that we submitted on the second guidance in the series (ii) “Cancer Clinical Trial Eligibility Criteria: Performance Status” is that we took a strong stance against using Performance Status as an eligibility criterion at all. The measures of performance status commonly used across cancer trial eligibility criteria, the Karnofsky Performance Status Score  (first developed in 1948) and ECOG Performance Status Scale (first developed in 1960), are outdated and highly subjective constructs. Their use as a proxy for disease progression in cancer trial eligibility criteria conflates illness with disability, and results in the discriminatory exclusion of many people with disabilities, which is counter to Section 504 of the Rehabilitation Act, Titles II or III of the Americans with Disabilities Act, and Section 1557 of the Affordable Care Act. We encourage FDA to adopt alternative measures that more appropriately reflect both the clinical risks (assessed by laboratory and diagnostic testing) and the individual participant’s experience and preferences.

June 25: (FDA-2024-D-1376). Our public comments on the third guidance (iii) “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications,” asked the FDA to clarify its use of the term “medication,” whether either the recommendations regarding concomitant medications or the washout period differ in the case of early (Phase 1/2a) versus late (Phase 3 and post-approval) trials, and when additional data and sub-studies might be needed to understand potential drug-drug interactions when participants are taking concomitant medications for chronic conditions.

In the Spotlight

Strengthening and Sustaining the Clinical Trial Ecosystem in Africa

AVAREF Advisory Committee

Barbara Bierer and Sarah White recently returned from a two-week work trip to Rwanda and Zimbabwe. The trip was motivated by the MRCT Center’s commitment to building clinical research capacity and a better understanding of local efforts to strengthen and sustain the clinical trial ecosystem. They first attended the African Vaccines Regulatory Forum (AVAREF) 14th Meeting of the Technical Coordinating Committee (TCC) and Steering Committee (SC) in Harare, Zimbabwe. The MRCT Center has partnered with AVAREF and, more broadly, with WHO for many years to build capacity for ethical review, optimize the integration of ethics review with regulatory processes, and strengthen the clinical trial ecosystem. To date, our work has included developing a fundamental research ethics training course (to be freely released in September 2024) and conducting site optimization visits to understand the challenges in clinical trial application reviews.

Dr. Bierer and Ms. White also spent time in Kigali, Rwanda, meeting with stakeholders, including the Rwanda FDA, Rwanda National Ethics Committee (RNEC), the University of Global Health Equity (UGHE), the UGHE Ethics Committee, the Butaro District Hospital, the Center for Family Health Research, and the Centre for Impact, Innovation, and Capacity Building for Health Information Systems and Nutrition (CIICHIN).

Working closely with the Bill and Melinda Gates Foundation and WHO, this trip provided significant insight into how the MRCT Center can collaborate with local stakeholders to improve the predictability, sustainability, and quality of clinical trials.

Click here to read more and view a slideshow of additional images.

Webinar: Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

How are people and organizations using the updated Clinical Research Glossary? Join us for an insightful webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center’s Clinical Research Glossary. Learn how this glossary can enhance the participant’s clinical research experience and how you can help shape the future of this resource, a resource recognized as a CDISC global standard.

Click here to register.

For more about the MRCT Center’s Clinical Research Glossary, including common questions, appropriate citation, and webinar recordings, click here.

On May 20, Clinical Trials Day, the National Academies of Sciences, Engineering, and Medicine (NASEM) hosted a hybrid public workshop of the Diversity Convergence Project, focused on building strategies for equitable participation, innovative trial design, and fostering community investment, engagement, and workforce development.

The need to improve diversity in clinical trials has been evident for many years, but a multi-sector action plan for system-wide, sustainable change was lacking. This critical work, initiated in June 2023 and led jointly by the MRCT Center, the Clinical Trials Transformation Initiative (CTTI), Milken Institute’s FasterCures, and the National Academies Forum on Drug Discovery, Development, and Translation, culminated in the recent release of the Toward A National Action Plan for Achieving Diversity in Clinical Trials framework. The plan, which outlines eight domains and actionable steps to drive system-wide collective action, aims to significantly increase the diversity of participants in clinical trials across the United States. This foundational framework document is a call to collective action. It has been (and continues to be) informed by the shared wisdom of hundreds of leaders in health equity and representation involved in a series of convenings over the last year.  

Publications

April 29: The MRCT Center submitted public comments to the FDA on collecting race and ethnicity data in clinical trials and clinical studies for FDA-regulated medical products.

Summary:

(FDA-2016-D-3561) The FDA will update this draft guidance document to align with new requirements published by the Office of Management and Budget. In the MRCT Center response, we (i) requested clarification on FDA’s expectations for how sponsors will use race and ethnicity data in shaping their clinical research endeavors; (ii) encouraged FDA to recommend the collection of geographic heritage as well as genetic ancestry; (iii) recommended FDA include specific guidance on whether and how such data may serve as Real World Data in support of regulatory submissions; and (iv) urged FDA to consider taking additional steps to ensure clinical trial representativeness.

April 30: The MRCT Center submitted public comments to the FDA on key information and facilitating understanding in informed consent: guidance for sponsors, investigators, and Institutional Review Boards.

Summary:

(FDA-2022-D-2997) The MRCT Center was encouraged by the FDA’s efforts to harmonize the informed consent regulations and guidance with the regulations and guidance of the federal Office for Human Research Protections (OHRP), the flexibilities incorporated into the guidance regarding informed consent forms (ICFs), and FDA’s emphasis on employing plain language throughout the informed consent process. We did offer suggestions for strengthening the guidance and specific comments on aspects of both the main text of the guidance and the hypothetical models included in the appendix. The Regulatory Affairs Professionals Society highlighted these comments after the comment period closed.

May 8: Katharine Wright, Willyanne DeCormier Plosky, Hayat Ahmed, Sarah White, and Barbara Bierer published “First, Do No Harm: A Global Perspective on Diversity and Inclusion in Clinical Trials” in Nature Reviews Drug Discovery.

In the Spotlight

LGBTQIA+ Resources

The need for participant diversity in clinical trials is well-recognized, but the inclusion of LGBTQIA+ individuals has often been overlooked. The MRCT Center established a working group comprised of experts from medical and research institutions, pharmaceutical companies, CROs, clinics, advocacy groups, and LGBTQIA+ community members to improve engagement and participation. The working group aims to advance a more comprehensive integration of inclusivity in clinical research, particularly addressing the historical underrepresentation of LGBTQIA+ individuals.  

The MRCT Center has developed two practical guides – the LGBTQIA+ Inclusive Imagery Case Study and an LGBTQIA+ Inclusive Language Checklist – to assist researchers in effectively including LGBTQIA+ individuals in clinical trials to ensure that study populations are truly representative.  

Additional tools will be released throughout the year, and they will address data collection, privacy, and accountability. These are part of a comprehensive effort to ensure that all potential participants, including the LGBTQIA+ community, see themselves reflected in clinical trial research and outcomes. 

Please contact us here if you would like additional information or periodic updates about this work.

Action and Influence: Implementing the Clinical Research Glossary and Your Critical Role in Public Review

How are people and organizations using the updated Clinical Research Glossary? Join us for an insightful webinar on Tuesday, June 4, from 11 – 12 PM ET to explore the practical uses and applications of the MRCT Center’s Clinical Research Glossary. Learn how this glossary can enhance the participant’s clinical research experience and how you can help shape the future of this resource, recognized as a CDISC global standard.

Topics:

• The Importance of Plain Language: Exploring how clear communication resources enhance understanding and trust-building.
• Real-World Applications: Discussing case studies where the glossary has been implemented.
• Public Participation in Public Review: Inviting feedback on proposed and existing glossary terms throughout the annual review cycle.

Click here to register.

For more about the MRCT Center’s Clinical Research Glossary, including common questions, how to cite the MRCT Center when using glossary resources in your materials, and resources, including slides and the recording from a recent webinar, click here.

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.

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.

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.

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.

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.

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.

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 7^th, and please register here.

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.

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.

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

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.

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.