Boston, MA – June 21, 2015 – The Center for Information and Study on Clinical Research Participation (CISCRP), an independent non-profit, is calling on U.S. regulators to address the unmet needs of patients involved in clinical research and improve transparency. With the support of hundreds of signatures from patients and professionals, CISCRP submitted a petition letter to the FDA urging the agency to help ensure study volunteers receive the results of their clinical trials directly, in lay non-technical language. CISCRP has also published a Letter to the Editor in the New England Journal of Medicine calling for trial results summaries to be provided for patients on ClinicalTrials.gov.
The Letter to the Editor, titled “Transparency and ClinicalTrials.gov Reporting: Have We Forgotten Patients?” was written by Zachary Hallinan and Kenneth Getz of CISCRP and Barbara Bierer of the Multi-Regional Clinical Trials Center at Harvard University. This letter responds to the March 2015 article, “Compliance with Results Reporting at ClinicalTrials.gov,” which addressed low compliance with ClinicalTrials.gov reporting requirements documented by Anderson et al.
The letter notes that “for nearly thirty years, researchers have been repeatedly documenting that clinical trial volunteers want and expect to be told what was learned as a result of their participation. Thanks to the efforts of European lawmakers, summaries of trial results will soon be available in everyday language to all EU citizens through a public registry, and it is clear that we must do no less for the millions of Americans who give the gift of their participation in clinical research.”
Hallinan, Getz, and Bierer urge readers to remember the importance of an equally-binding obligation to share research findings with the clinical trial participants who make advancements in medical research possible. The authors also point to evidence of the value of sharing results in understandable language and how this can be effectively put into practice. For example, most participants (77%) are never told their trial’s results, and 72% say this is “very important” to address.(3) A new Institute of Medicine report calls sharing results in understandable language a “matter of public transparency and respect”, and cites CISCRP research demonstrating feasibility.(4)
Over the past five years, CISCRP has developed and tested a program to help address this unmet need. Working through an editorial panel of medical and health communications experts as well as patient advocates, CISCRP “translates” the technical results of clinical trials into scientifically accurate, non-promotional lay summaries written at a validated 6th-8th grade reading level. Globally conducted evaluations have shown that volunteers’ comprehension of the trial results improves dramatically after independent review of CISCRP lay-language summaries, and over 90% of volunteers indicate satisfaction with their level of understanding. The Communicating Trial Results program was recognized in 2013 with a Human Research Protection Best Practice award by the Health Improvement Institute.
CISCRP is nonprofit organization that is dedicated to providing, educating, and informing the public, patients, medical/research communities, media, and policy makers about clinical research and the role each party plays in the process. For more information, visit https://www.ciscrp.org.
Maya Wise, Marketing and Communications Manager