Return of Aggregate Results

Return of Aggregate Results

Participants do not consistently receive summary results information about the studies they contributed to. Returning results in plain language improves the transparency of trials, builds trustworthiness in the clinical trial industry, and honors the essential contributions and voluntarism of study participants. To do so involves communication—in language understandable to the participants—of the results of the trial and the outcome of the study as a whole.

Since 2013, the MRCT Center and its collaborators have focused on ways to lower barriers for returning results, creating useful tools and guidance 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 an updated Guidance Document and Toolkit in 2017.

Recommendations from the Guidance and Toolkit were further incorporated into EMA regulation in 2017 and 2018 and an MRCT Center draft guidance on the Provision of Plain Language Summaries was submitted to the FDA in 2017.

Appreciating the complexity of this topic, the MRCT Center continues to remain abreast of return of results opportunities. 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 integrating health literacy principles in the sharing of Plain Language Summaries.

Most recently, along with the NIH Office of Science Policy, the MRCT Center co-hosted a listening session to collect feedback on a forthcoming NIH policy on returning study results to participants. The MRCT Center is primed to respond, advise, and engage as this area continues to evolve.

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

April 2026: Co-hosted listening session webinar with NIH on new return of results policy
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

CLINICAL TRIALS & RESEARCH

Return of Aggregate Results