Improve Your Approach to Sharing Clinical Trial Data

Improve Your Approach to Sharing Clinical Trial Data

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.

Best practices for sharing clinical trial data

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?

By crafting all the documents required by the health authorities, regulatory writers have the greatest command of the clinical trial data which is subject to disclosure requirements. Moreover, regulatory writing groups have a deep understanding of all the nuances of the various laws that clinical operations and regulatory affairs staff simply lack. By entrusting this work to the experts, sponsors are able to satisfy these requirements more quickly and with greater peace of mind.

For instance, my team might work with a client that is looking to meet regulatory requirements in both the US and Europe. In this case, we can develop strategies that support protocol registration and results disclosure to ClinicalTrials.gov and EudraCT simultaneously and/or produce redacted clinical documents and lay summaries, according to policy and business rules. Writers familiar with the disclosure landscape can quickly identify additional data that must be generated for registration purposes (data outside of what is usually produced for a CSR) while programming and biostatistics are already supporting the project. And in addition, while time lines and review teams are assembled, the disclosure activities are already being taken into account. They are pre-planned, rather than an after-thought or hand off to another group. This integrated, streamlined approach helps our clients satisfy compliance and consistency requirements to reduce risk and, ultimately, save time and money in the long run.

Mastering the art of scientific communication

The challenges of communicating complicated science to non-scientists was succinctly summarized by a quote attributed to Albert Einstein:

“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 Center for Information and Study of Clinical Research Participation (CISCRP)—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 to integrate these initiatives into your processes? Please read a white paper that we’ve written on this subject. Let me know what you think in the comments!

Kim Green

About the Author

Ms. Green, who joined Synchrogenix in 2003, is the Director of Team Leads and a senior regulatory writer with a background in preclinical, clinical, and drug safety documents. Among her work, Ms. Green has produced and led other writers in producing a variety of regulatory documents, including clinical study reports (CSRs), periodic safety update reports (PSURs), investigator’s brochures (IBs), integrated summary documents for submission, as well as research methods, reports, and training documents. Ms. Green has also registered clinical trials protocols and posted results to the Protocol Registration System (PRS) and EudraCT, performed quality review for safety reports in multiple therapeutic areas, and has developed internal reports for new pharmaceutical product submission, including formatting to comply with client style guides and evaluating lab data.