The Center for Information and Study on Clinical Research Participation (CISCRP) and Synchrogenix, Certara’s regulatory writing consultancy, are collaborating to develop lay summaries of clinical trials for the general public
PRINCETON, NJ – 2015 年 4 月 23 日 – Certara®, the global biosimulation technology-enabled drug development consultancy and the nonprofit Center for Information and Study of Clinical Research Participation (CISCRP), today announced an exclusive partnership to provide lay language clinical trial results to clinical trial volunteers. Through this collaboration, Synchrogenix, Certara’s regulatory writing consultancy, significantly increases global medical writing capabilities supporting an initiative that CISCRP pioneered four years ago.
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 the 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, added that “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.”
Communicating Trial Results to Study Volunteers – An Ethical Obligation
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.
CISCRP is nonprofit organization that is dedicated to providing, educating, and informing the public, patients, medical/research communities, media, and policy makers about clinical research and the role each party plays in the process. For more information, visit https://www.ciscrp.org.
Synchrogenix, Powered by ClinGenuity and part of Certara, encompasses a group of separate entities operating together to provide regulatory writing services to the pharmaceutical, biotech, and medical device industries worldwide. Synchrogenix Information Strategies Inc.; Synchrogenix Europe, Ltd.; and Synchrogenix Philippines, Inc. (SPI) are all wholly owned subsidiaries with an overall governance structure that creates and enforces a global standard of service, technology, and quality.
Certara is a global biosimulation technology-enabled drug development consultancy. Its customers include hundreds of biopharmaceutical companies around the globe, together with several regulatory agencies. Certara’s solutions, which span the discovery, preclinical and clinical stages of drug development, enable data-driven decisions, leading to more precisely designed trials with a reduced risk of failure and improved subject safety. For more information, visit www.certara.com.
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