Return of Aggregate Results
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from the Guidance and Toolkit were incorporated into EMA regulation in 2017 and 2018 and the MRCT Center submitted draft guidance on Provision of Plain Language Summary to the FDA in 2017.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”
- December 2018: Returning aggregate results of clinical trials: Empirical data of patient preferences, published in the Journal of Clinical and Translational Science
- December 2017: Version 3.1 of MRCT Center Return of Aggregate Results to Participants Guidance Document and Version 3.1 of MRCT Center Return of Aggregate Results to Participants Toolkit released and Return of Aggregate Results to Participants Principles Version Nov 2017 released
- October 2017: Submitted Draft Guidance on Provision of Plain Language Summaries to FDA
- 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
Project Resources
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Public Comments
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Publication
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Annual Report
December 15, 2022
2022 MRCT Center Annual Report ›
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Presentation
January 15, 2020
Expectations of ‘Good Lay Summary Practices’ ›
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Presentation
January 15, 2020
Dissemination strategies and options for plain language summaries ›
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Public Comments
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Presentation
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Publication
December 1, 2018
Returning Aggregate Results of Clinical Trials ›
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Principles
December 7, 2017
Return of Aggregate Results to Participants ›
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Guidance
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MRCT Sponsor Resource
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Tools
December 6, 2017
MRCT Return of Aggregate Results Toolkit Version 3.1 Word Document ›
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Tools
December 6, 2017
Return of Aggregate Results to Participants Toolkit Version 3.1 ›
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Guidance
September 6, 2017
Draft FDA Guidance on Provision of Plain Language Summaries ›
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Presentation
July 10, 2017
Fourth Clinical Regulatory Medical Writing Forum ›
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Presentation
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Presentation
January 31, 2017
CBI Clinical Data Disclosure and Transparency Conference ›
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Presentation
September 19, 2016
Ensure Efficient Return of Aggregate Trial Results with the MRCT Toolkit ›
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Presentation
July 12, 2016
Third Clinical Regulatory Medical Writing Forum ›
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Presentation
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Presentation
January 28, 2016
Responsible Clinical Trial Data Sharing ›
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MRCT Sponsor Resource
November 13, 2015
MRCT Center Return of Results Project Slides 2015 ›
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Presentation
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Presentation
September 18, 2015
DIA Clinical Trial Data Sharing ›
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Presentation
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Publication
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Presentation
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Presentation
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Public Comments
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Presentation
February 19, 2015
Practical Implementation of Return of Results to Patients ›
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Public Comments
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Presentation
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Proceedings
December 3, 2014
Harvard MRCT Annual Meeting 2014 ›
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Presentation
December 3, 2014
Harvard MRCT Annual Meeting Return of Results Slides ›
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MRCT Sponsor Resource
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Presentation
December 3, 2014
MRCT Center 2014 Annual Meeting Slides ›
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Presentation
November 5, 2014
Return of Results Initiative ›
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Presentation
October 16, 2014
Patient Participation in Clinical Trials ›
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Presentation
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Public Comments
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Public Comments
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Presentation
February 3, 2014
Guiding Principles for Clinical Trials 2014 ›
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Publication
October 24, 2013