New BMJ Policy Requires Clinical Trial Data Sharing
July 6, 2015
CISCRP Revamps its Educational Brochures
July 7, 2015
Show all

Clinical Trial Results Communication Takes Center Stage

CISCRP is continuing to call attention to the need for transparency and the importance of lay language trial results. One of our most important activities was a petition to the FDA Commissioner, with over 400 signatures, calling for easy to understand summaries of trial results on the U.S. government’s ClinicalTrials.gov database. We were supported in this effort by numerous patient advocacy organizations and other stakeholder groups, and would like to extend a special thanks to CureClick, ACRP, Parkinson’s Disease Foundation, and BreastCancerTrials.org.

Together with the Harvard MRCT Center, we also published a letter to the editor in the New England Journal of Medicine highlighting the need for transparency not just to other researchers, but also to the patients who make clinical research possible. This letter responds to a March 2015 article addressing low compliance with ClinicalTrials.gov reporting requirements and asserts lay language trial results for participants as an obligation of research professionals.

In Europe, public posting of lay language trial results will be required for interventional trials as early as May 2016. The European Union will enforce such regulations in conjunction with their increased medical transparency legislation, which requires lay language summaries be provided to trial participants within one year of the trial’s conclusion. The lay summaries CISCRP produces through its Communicating Trial Results program are already meeting these requirements.

Similar conversations around transparency have circulated in the U.S. as well, calling for the same precedent to be set for making lay language summaries available to patients. The Institute of Medicine’s July 2014 report on sharing clinical trial data made an explicit recommendation for these summaries to be made available to study participants in the same one-year timeframe, referencing CISCRP’s work and best practices.

CISCRP is pushing to make clinical trial results disclosure to study volunteers a standard industry practice, and we are making excellent progress. The Communicating Trial Results team at CISCRP is currently working with more than 30 of the top 50 largest sponsor companies to provide lay language trial results summaries to study volunteers.

To learn more about CISCRP’s Communicating Trial Results program, please contact the team at trialresults@ciscrp.org.

Read the next article >>

Comments are closed.