Discussion topic: The FDA Office of Minority Health and Health Equity at the U.S. Food and Drug Administration (FDA) presents a webinar featuring Drs. Barbara E. Bierer (Faculty Director, MRCT Center; Professor of Medicine, Harvard Medical School) and Luther T. Clark (Deputy Chief Patient Officer, Merck).
Drs. Bierer and Clark will introduce the recently released MRCT Center’s Diversity Framework, titled Achieving Diversity, Inclusion, and Equity In Clinical Research. After providing a brief introduction, background, and contextual orientation to listeners, Drs. Bierer and Clark will highlight the ways in which stakeholders can contribute to increasing diverse representation in clinical research and, ultimately, improving health equity and public health domestically and abroad.
Returning results in plain language allows for investigators and sponsors to honor the essential contributions and voluntarism of study participants in multi-regional clinical trials, while improving the transparency of those trials. Returning the summary results of a clinical trial to participants involves communication—in language understandable to the participants—of the results of the trial and the outcome of the study as a whole.
Launched in 2013, the MRCT Center and its collaborators developed resources to lower barriers for returning results, created a number of useful tools, and published a guidance for the clinical trial community. The practical guidance document and toolkit were developed for use by all clinical trial sponsors, including academia, industry, non-profit and government organizations.
The workgroup first presented the results of its efforts at the U.S. Secretary’s Advisory Committee on Human Research Protections (SACHRP) and at the MRCT Center Annual Meeting in December 2014 and released the first version of its Guidance Document and Toolkit three months later. Updates to the Guidance Document and Toolkit were made in 2016 and 2017. Recommendations from the Guidance and Toolkit were incorporated into EMA regulation in 2017 and 2018 and the MRCT Center submitted draft guidance on Provision of Plain Language Summary to the FDA in 2017.
Appreciating the complexity of this topic, the MRCT Center has continued to remain abreast of challenges in the return of results space. We have explored the topic of returning summary results in comprehensive and integrative medicine, as well as launched separate projects delving deeper into returning individual results to participants, and addressing health literacy principles in clinical research that extend to the sharing of Plain Language Summaries. In 2023, the MRCT Center worked with Institutional Review Boards around the country to identify opportunities for returning results to participants within academic health centers and continues to advocate for a centralized location for the sharing of patient-centric study results summaries.
OBJECTIVES
Raise awareness of academia’s responsibility to fulfill the ethical obligation of returning results to participants
Promote greater understanding of procedural and operational requirements for returning aggregate results
Increase the frequency of returning results to participants for all types of studies
Reduce barriers to implementing return of results policies, with a focus on operational elements
Amplify patient/participant voice and preferences for receiving aggregate results
Key milestones
August 2022: Launched workgroup “Return of Results in Academia”
March 2017: Version 3.0 of MRCT Return of Aggregate Results Guidance Document and Version 3.0 of MRCT Return of Aggregate Results Toolkit released
December 2016: Return of Aggregate Results to Participants Principles Document released
July 2016: Version 2.1 of MRCT Return of Results Guidance Document and Version 2.2 of MRCT Return of Results Toolkit released
March 2016: Version 2.0 of MRCT Return of Results Guidance Document and Version 2.1 of MRCT Return of Results Toolkit released
October 2015: Version 2.0 of MRCT Return of Results Toolkit released
March 2015: Version 1.0 of MRCT Return of Results Guidance Document and Toolkit launched and harmonized with existing and ongoing efforts
December 2014: MRCT Center Annual meeting – working draft presented of Return of Results Guidance Document and Toolkit and panel discussants from EMA, FDA, OHRP and patient advocates discussed the MRCT Center approach to returning aggregate results to trial participants
January 2014: MRCT Center multi-stakeholder working group launched, comprised of 53 leaders in academia, industry, patient advocacy and health literacy
December 2013: MRCT Center Annual meeting – engaged a diverse multi-stakeholder group in identifying key issues and barriers to returning results and formulating tangible deliverables
Project leadership & Staff
The original project (2013-2017) was co-chaired by:
Barbara E. Bierer, MD. Faculty Director, MRCT Center
Deborah Collyar, BSc. President, Patient Advocates in Research
Laurie Myers, MBA. Global Health Literacy Director, Merck
Carmen Aldinger, PhD, MPH, PMP, Program Manager
The workgroup for the project update (2022 to current) is co-chaired by:
Barbara E. Bierer, MD. Faculty Director, MRCT Center
Sylvia Baedorf Kassis, MPH. Program Director, MRCT Center
Keren Dunn, Executive Director, Research Compliance & Quality Improvement, Cedars-Sinai
Ann Johnson, PhD, MPH, CIP. IRB Director, University of Utah
Liz Martinez, RN, BSN, CCRC. Johns Hopkins University
Kristin Bartlett, Program Coordinator, MRCT Center
The MRCT Center worked with high school and college students to develop educational brochures on various research topics. These brochures were reviewed by international youth advisory networks and are written for 12- to 17-year-olds.
