By Rachel Minnick
Since 2009, CISCRP has been working with pharmaceutical, biotechnology and medical device companies to create and disseminate plain language summaries for clinical trial participants under its Communicating Trial Results program. During the past seven year we have seen tremendous interest and growth in the program as more sponsor companies pilot and adopt this initiative among their patient engagement practices. There has been a significant call-to-action to include Communicating Trial Results programs to support clinical trial transparency, and to demonstrate that study volunteers are valued partners in the clinical research process.
At the present time, CISCRP is working with more than 30 major sponsor companies to provide trial results summaries on a study-specific basis and increasingly under portfolio-wide arrangements. CISCRP’s plain language summaries are offered in paper and digital formats.
Communicating Trial Results programs are essential to building trust among patients. Many sponsors will soon be a required to submit their lay language summaries to the online EU Public Portal under the new European Union Clinical Trials Regulation. Although the FDA has not mandated that sponsors provide lay language summaries, a growing number of companies anticipate that doing so will become a standard practice in the United States.
During the past 24 months, CISCRP’s team supporting the Communicating Trials Results program has grown dramatically. The team includes dedicated regulatory writers, senior editors with expertise in plain language communication principals, and patient representatives.
Jill McNair, Senior Director of Patient Engagement who oversees the Communicating Trials Results program at CISCRP, remarked “We’re working with a growing number of sponsor companies who recognize that communicating trial results is not only the ethical thing to do but also the right thing to do. We’re helping sponsor companies integrate this important process into their clinical research operations to drive higher levels of patient engagement.”
CISCRP is also leveraging its well-established Communicating Trials Results processes and dedicated editorial panels to help companies apply similar principles to other important plain-language clinical trial communications including informed consent documents, risk management summaries, and ongoing communications.
CISCRP’s is honored to have its award-winning Communicating Trial Results program recognized as a leading service and an emerging standardized practice. For more information, contact Jill McNair (JillMcNair@ciscrp.org) or go to Communicating Trial Results.