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.
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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.