Transparency and disclosure of clinical trial data has been a hot topic, growing in prominence and strategic discussions over the past few years. Disclosing clinical trial information and creating transparency around clinical trial results are key steps toward increasing trust between the public and the industry. Increased transparency regarding data about ongoing research could spur new products or therapeutic approaches and potentially avoid unnecessary trials.
From ClinicalTrials.gov to EudraCT, and from redacted clinical trial reports to lay summaries, there are a number of platforms and opportunities from which to share data with the public. Pharmaceutical, biotech, and academic researchers need to be conscious of the regulations, stay ahead of the game, and put the most efficient practices in place to keep up with the evolving disclosure landscape. In this blog post, I’ll discuss why the best practices for meeting these regulations involves leveraging the unique skill set and knowledge of regulatory writing groups.
A 10,000 foot view of the regulatory landscape
The clinical study report (CSR) is a foundational document in the drug development process. It presents the methods and results of a clinical trial. A CSR also addresses the efficacy and safety aspects of a drug and has a structure similar to a peer-reviewed academic paper. Transparency and disclosure regulations mandate sharing clinical trial data in documents like CSRs with the public and scientific community. At Synchrogenix®, part of Certara®, we focus on these areas:
- ClinicalTrials.gov: Section 801 of the Food and Drug Administration Amendments Act (FDAAA) requires sponsors to register studies and report study results at this online database. The EMA has similar legislation regarding posting clinical trial results summaries to EudraCT- the European Clinical Trials Database.
- EudraCT and Redaction: European Medicines Agency (EMA) Policy 70, Publication of Clinical Data for Medicinal Products for Human Use, requires all CSRs that support an approved marketing authorization are made publicly available. To achieve compliance with these mandates, academic institutions, pharmaceutical and biotech companies will need to post results to EudraCT and/or redact and de-identify data sets in their clinical study reports and submission documents and publish their clinical study information publicly.
- Lay Summaries: Clinical trial results summaries are written in highly technical language that is not accessible to the general public, including clinical trial volunteers. Thus, lay summaries— brief, plain-language accounts of a clinical trial’s design, objectives, and findings— are critical to helping inform and educate clinical trial volunteers. The Pharmaceutical Research and Manufacturers Association (PhRMA) and European Federation of Pharmaceutical Industries Association (EFPIA) have made commitments to transparency initiatives for layperson summaries. Likewise, there are similar pending European Union requirements. With increasing and impending regulation, sponsors are feeling the pressure to proactively address the demands of disclosure to the community.
Over the years, I have seen clients assign the work of meeting transparency and disclosure requirements to various internal groups, usually the regulatory affairs or clinical operations group. At first glance, this may seem to be a logical, cost-saving choice. In reality, I can assure you that it almost always ends up being more time consuming and expensive than entrusting this work to regulatory writing experts. Why is this?
“If you can’t explain it simply, you don’t understand it well enough.”
Regulatory writers are experts in the art of scientific communication. Our passion for educating clinical trials volunteers dovetails perfectly with our partnership with the—an organization dedicated to educating and informing the public and patients about pharmaceutical research. This exclusive partnership was forged to provide lay language clinical trial results to clinical trial volunteers. Through this collaboration, Synchrogenix significantly increases global medical writing capabilities supporting an initiative that CISCRP pioneered four years ago. 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. Indeed, more than two dozen industry sponsors have begun implementing lay-language communication programs with CISCRP. Partnering with us enables CISCRP to dramatically expand their ability to meet sponsor requests while ensuring non-promotional and scientifically accurate communication through CISCRP’s proven process and independent, neutral nonprofit status.
Learn more about meeting transparency and disclosure initiatives
Are you struggling? Please read a white paper that we’ve written on this subject. Let me know what you think in the comments!