May 2024 Newsletter

In the Spotlight

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.

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.

Join us for a webinar on Sexual Orientation and Gender Identity (SOGI) Data in Clinical Research on Tuesday, June 11, from 12 – 1 PM ET. We will discuss key points from the SOGI Data Collection Checklist and SOGI Data Privacy Checklist, which will be released the same day, as part of the LGBTQIA+ Inclusion by Design in Clinical Research Toolkit. The importance of representation, key points to consider, and implementation examples will be discussed. These tools build upon numerous efforts to develop guidance, test methodologies, and share lessons learned. Everyone should be able to see themselves in clinical research data and feel secure that their data is treated with respect and confidentiality.

Click here to register.

We look forward to sharing this important work with you.

The Multi-Regional Clinical Trials (MRCT) Center’s Joint Task Force for Clinical Trial Competency (JTF) is dedicated to enhancing standards and practices within the clinical research field. The JTF aims to foster a cohesive approach to advancing clinical research, ensuring that professionals have the necessary competencies to conduct clinical trials effectively and ethically. More specifically:

Biannual Meeting Announcement

Please join us for our upcoming biannual meeting on June 6 from 9 – 11 AM ET. The agenda includes: 

We look forward to your participation and valuable contributions to these important discussions. 

Click here to register.

The MRCT Center has collaborated with a multistakeholder group on the Equitable Access to Clinical

Trials (EACT) project, hosted by LUNGevity Foundation, to share best practices and promote financial neutrality for patients in clinical trials.

Clinical trials are essential for developing new treatments but need more enrollment and participant diversity. Lower-income patients are especially underrepresented due to costs, with those earning less than $50,000 per year being nearly 30% less likely to join cancer trials. Participation can also financially burden caregivers.

Non-medical out-of-pocket costs include travel, meals, caregiving, and time away from work. Despite some sponsor support, these costs can still be barriers.

The EACT project offers resources to reduce financial burdens:

  • Best practice considerations and recommendations guide for sponsors
  • Tools for trial site personnel to assist in conversations with sponsors and patients
  • Patient needs assessment checklist for identifying non-medical financial needs
  • Policy recommendations to address tax and legal issues hindering financial support

The EACT project was recently profiled in STAT News. Click here to read the article.

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.  

May 1: Barbara Bierer presented at Health Resources in Action (HRA)’s “Promoting Diversity in Clinical Trials” webinar, addressing the levers funders can use to advance representation in clinical trials and examples of guidance that funders can provide applicants.

May 3 – 15: Barbara Bierer and Sarah White traveled to Zimbabwe and Rwanda to better understand local efforts to strengthen and sustain the clinical trial ecosystem to support the MRCT Center’s commitment to building clinical research capacity. See the Spotlight above.

May 8: Carolyn Chapman presented a poster, “Delivering on the Ethics of Gene Therapy Trials,” at the American Society of Gene and Cell Therapy (ASGCT) annual convention. 

May 14: Sylvia Baedorf Kassis presented at the Institution for Healthcare Advancement’s annual Health Literacy Conference on “Meaningful Participant Engagement: Strategies to Include Diverse Perspectives from Program Development through Implementation.”  

May 16: Sylvia Baedorf Kassis moderated an expert panel and was featured as a speaker at Citeline’s TrialScope EXTRA event focused on trial transparency and disclosure processes.

May 20: Barbara Bierer presented “Diversity Convergence Project: Toward a National Action Plan for Achieving Diversity in Clinical Trials” at the National Academies of Science, Engineering, and Medicine. See above.

May 23 – 25: AAHRPP Annual Conference

  • May 22: Barbara Bierer co-presented with Anne Le Goff and Arash Naeim on “Safeguarding Participants in Emerging Technologies: Ethical Considerations in Clinical Trials.”
  • May 23: Barbara Bierer co-presented with Megan Kasimatis Singleton on “Has the Short Form Lost its Place in Research Consenting?”
  • May 23: Willyanne DeCormier Plosky presented with Katherine McDonaly on a panel entitled “Engaging People with Disabilities in Clinical Research Planning, Conduct, and Review.”
  • May 23: Barbara Bierer co-presented with Martha Jones on “Enhancing Justice and Access: DEI Resources, Tools, and Recommendations for IRBs and HRPPs.”
  • May 23: Lisa Koppelman co-led a session entitled “Including Young People in Research: How to Walk the Walk” with Dr. Gianna McMillan.

May 28: Dr. Barbara Bierer presented “The clinical trial ecosystem, IRB, investigators, health systems and regulatory authority–roles and responsibilities, and requirements” at the joint US FDA and Costa Rica symposium: Clinical Trials and Operational Considerations.

May 29-30: Meeting of the MRCT Center’s External Advisory Board and the Executive Committee.

June 4, 11 AM- 12 PM ET: “Action and Influence – Implementing the Clinical Research Glossary and Your Critical Role in Public Review” webinar. See Spotlight above.

June 11, 12 – 1 PM ET: “Data Collection and Privacy: LGBTQIA+ Tools and Resources” webinar. See Spotlight above.


June 18, 9:30 AM – 12 PM ET: Meeting of the Bioethics Collaborative (BC). Topic: Reciprocity in Research: What do we owe host communities? Open to sponsors of the Bioethics Collaborative.

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.


(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.


(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.

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.