Return of aggregate results
Focus Area: Data Transparency
Returning aggregate results refers to providing clinical trial participants with plain language summaries of the trial results and information about the outcome of the study as a whole.
While major organizations, including the World Medical Association and the European Medicines Agency have called for sponsors to institute results return programs, sponsors currently face a number of both logistical and regulatory challenges before instituting a return of results initiative.
With these challenges in mind, the MRCT Center undertook this project to bring a multi-stakeholder solution to lowering barriers for returning results and creating useful tools and guidance for the clinical trial community.
Current status: Dissemination of Return of Results Guidance Document and Toolkit
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.
- Review current efforts and regulations in returning aggregate results to study participants
- Create a guidance document and toolkit that will detail process, logistics and content for how to return aggregate results to participants.
- Disseminate materials for review
- Harmonize with existing efforts
Key project milestones:
Project co-chairs: Deborah Collyar (Patient Advocates in Research), Laurie Myers (Merck)
- 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 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:
Deborah Collyar, Patient Advocates In Research (PAIR) and Co-Chair of MRCT Center’s Return of Aggregate Results Workgroup, explains why sharing results are good for patients and the research community
Program Manager: Carmen Aldinger