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Return of Aggregate Results

Focus Area: Transparency

Return of Aggregate Results

Returning the summary results of a clinical trial to participants involves communication, in plain language understandable to the participants, 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 MRCT Center Annual Meeting in December 2014, and released the first version of its Guidance Document and Toolkit three months later. The documents have been updated approximately annually to respond to feedback and evolving practices.

Appreciating the complexity of this topic, the MRCT Center has continued to evolve this project, including framing issues arising in returning summary results in non-Western cultures, launching a separate project on returning individual results to participants, and currently addressing health literacy principles in clinical research.

Current status: Dissemination

Impact: 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.

Objectives:

  • Review and revise Principles, Guidance Document, and Toolkit, as needed, in response to feedback and evolving policy
  • Disseminate materials

Project co-chairs: Deborah Collyar (Patient Advocates in Research), Laurie Myers (Merck), Barbara Bierer (MRCT Center)

Key project milestones:

  • 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
  • January 2014: MRCT Center multi-stakeholder working group launched, comprised of 53 leaders in academia, industry, patient advocacy and health literacy
  • September 2014: Draft of Return of Results Guidance Document and Return of Results Toolkit finalized at in-person workgroup meeting at Harvard
  • 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
  • March 2015: Version 1.0 of MRCT Return of Results Guidance Document and Toolkit launched and harmonized with existing and ongoing efforts
  • August 2015: Launched project to return aggregate results in non-Western culture in collaboration with the Comprehensive and Integrative Medicine Institute (CIMI) at Daegu Catholic University Medical Center in Daegu (DCUMC), South Korea
  • October 2015: Version 2.0 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
  • July 2016: Version 2.1 of MRCT Return of Results Guidance Document and Version 2.2 of MRCT Return of Results Toolkit released
  • December 2016: Return of Aggregate Results to Participants Principles Document released
  • 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
  • October 2017: Submitted Draft Guidance on Provision of Plain Language Summaries to FDA
  • 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

Related external links:

European Commission’s Summary of Clinical Trial Results for Laypersons

Secretary’s Advisory Committee on Human Research Protections (SACHRP) Recommendations Regarding Return of General Research Results

Program Manager: Carmen Aldinger