Synchrogenix, CISCRP partner on clinical data transparency requirements
Synchrogenix, the regulatory writing consultancy of Certara, a global biosimulation technology-enabled drug development consultancy, and the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP) have partnered to provide lay language clinical trial results to clinical trial volunteers.
On behalf of pharmaceutical, biotechnology and medical device companies, CISCRP and Synchrogenix will jointly provide clinical trial participants with high-quality, written summaries of their trial’s results, in alignment with Pharmaceutical Research and Manufacturers Association (PhRMA) and European Federation of Pharmaceutical Industries Association (EFPIA) transparency commitments and pending European Union requirements for layperson summaries. These summaries are brief, plain-language accounts of a clinical trial’s design, objectives and findings.
“With increasing and impending regulation, sponsors are feeling the pressure to proactively address the demands of disclosure to the community,” said Kelley Kendle, Synchrogenix president and CEO. “This new partnership combines Synchrogenix’s technology-enabled operational expertise and clinical writing talents with CISCRP’s unbiased governance and dedication to engaging patients and the public in the spirit originally intended of the clinical research process.
Zach Hallinan, CISCRP’s director of Patient Communication and Engagement Programs, said, “More than two dozen industry sponsors have begun implementing lay-language communication programs with CISCRP. By partnering with Synchrogenix, a market leading global provider of medical and regulatory writing services, we can dramatically expand our ability to meet sponsor requests while ensuring non-promotional and scientifically accurate communication through CISCRP’s proven process and independent, neutral nonprofit status.”
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 mattered or was appreciated.
Over the past five years, CISCRP has developed and tested 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. User- and field-testing in the context of global trials shows that volunteers’ comprehension of the trial results improves dramatically after independent review of a lay-language summary, and over 90% of volunteers indicate satisfaction with their level of understanding. The program was recognized in 2013 with a Human Research Protection Best Practice award by the Health Improvement Institute.
Synchrogenix’s medical writers will develop the text and images for each lay summary, leveraging its artificial intelligence technology platform, and implementing the company’s quality control processes to ensure data and message accuracy. CISCRP will deliver a critical, unbiased review of the report, engage and interact with investigative sites 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.