Since 2011, CISCRP and clinical research sponsors have worked together to address a critical unmet need in the research enterprise:
Studies consistently show that most clinical trial participants want to know what the research community learned from their participation, yet most never hear from the sponsor or research site staff at all after a clinical trial has concluded.
CISCRP has developed and tested a program to provide study volunteers with the results of their clinical trial. Working through our 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.
Prepared in printed, electronic and audio formats to accommodate different learning styles, the summaries are disseminated to volunteers via their investigative site as a way to fulfill researchers’ ethical obligation to return trial results, and demonstrate to volunteers that they are respected as true partners in the clinical research process.
Click the image to the left to view “Creating a Standard Practice for Communicating Lay Language Trial Results to Study Volunteers”, our most recent publication about the Communicating Trial Results program in the journal Research Practitioner.
This article provides context for the critical obligation to provide lay language results to study volunteers, discusses efforts underway to establish standard practices to routinely deliver these results, and describes the anticipated impact of these programs.
Our research indicates that volunteers’ comprehension of the trial results improves dramatically after independent review of a lay-language trial results summary, and over 90% of volunteers indicate satisfaction with their level of understanding.
Given the positive experiences most volunteers (84%) have in trials, and the strong response we have seen to our program, we believe that sponsors and researchers can influence more positive trial participation experiences, and build a substantial base of public support for clinical research, by implementing a program for systematically communicating trial results to all volunteers who give the gift of their participation in clinical research.