In 2011, CISCRP launched a first-of-its-kind program to help share clinical trial results with the patients who made the research possible. From the onset, the Communicating Trial Results program was designed to help trial volunteers learn about the results of their trial and to show that they are respected by the research community as true partners in the search for better or new medicines.
Today, more than twenty research sponsors share results of their clinical trials with patients through CISCRP’s program. Our approach informs patients with updates on when they will receive the trial’s results, provides educational content about clinical research, and also thanks patients for their role in advancing medical science. The trial results are prepared in a summary report written in everyday language that is delivered to study centers, who then share the reports with the study volunteers.
Through focus groups, interviews, and surveys, CISCRP has found that 91% of patients are satisfied that the lay-language Trial Results Summaries provide the information they need to know, and in a way that helps them understand what was learned. In 2013, the program was acknowledged with the Health Improvement Institute’s 2013 Award for Excellence in Human Research Protection.
Since CISCRP started this program, the research enterprise has seen a significant shift toward greater transparency and “patient centricity.” In 2013, for example, the Declaration of Helsinki guidelines on ethical standards in human research were updated to include this statement: “All medical research subjects should be given the option of being informed about the general outcome and results of the study.”
Similarly, PhRMA and EFPIA, the US and European trade organizations for clinical research companies, issued a joint statement last year committing to “sharing results with patients who participate in clinical trials”. And in April of 2014, European lawmakers voted to require lay-language summaries of results for studies conducted in the European Union.
Between growing regulatory requirements and commitments from clinical research sponsors, there is hope that all patients will soon be told the results of their trial. For most study volunteers and research professionals, the only question left is, “How soon can we make it happen?”
If you would like to learn more about CISCRP’s Communicating Trial Results program, or provide support for this important initiative, please contact us.