A New Model to Meet BioPharm Transparency Mandates and Engage Participants as Clinical Research Partners
Studies consistently show that 90% of clinical trial volunteers expect to be told the overall results of their trial. Unfortunately, most never hear anything back from the Sponsor or research center after the last study visit, leaving many volunteers wondering if their participation was valued or appreciated.
Over the past five years, the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) has developed a program to help sponsors 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.
Last year, Synchrogenix, Certara’s regulatory writing consultancy, and CISCRP formed a partnership. The medical writers at Synchrogenix develop the text for each lay summary and implement the company’s quality control processes to ensure data and message accuracy. CISCRP delivers a critical, unbiased review of the report, engage and interact with investigative sites, create patient-friendly images, and manage production, dissemination, and communications of the report. Working together, the two organizations have developed a consistent, sustainable delivery model that will help to ensure that all the stakeholders in a clinical trial are fully informed.
This webinar discussed best practices for sharing plain language trial results as a foundation for helping ensure that patients who give the gift of study participation have the opportunity to understand their contribution to advancing medical science.