Return of Aggregate Results
Focus Area: Transparency
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from the Guidance and Toolkit were incorporated into EMA regulation in 2017 and 2018 and the MRCT Center submitted draft guidance on Provision of Plain Language Summary to the FDA in 2017.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 evolve this project, including framing issues arising in returning summary results in comprehensive and integrative medicine, as well as launched separate projects on returning individual results to participants, and addressing health literacy principles in clinical research.
Key project milestones:
- 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- October 2017: Submitted Draft Guidance on Provision of Plain Language Summaries to FDA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
This project 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