Clinical Data Transparency & Public Disclosures: Overcoming Challenges With Prospective Writing

By Adiba Kausar, Clinical Trial Disclosure Administrator, TransPerfect Life Sciences

In the regulatory writing industry, prospective writing can be an enticing approach if adopted strategically. Thinking about future outcomes in response to current actions is an obligatory precedent to strategic decision-making.

Regarding the ever-changing concept of data transparency, an association can be established by linking protocols, clinical study reports, informed consent forms, publicly disclosed clinical trial results, and corresponding manuscripts. Although each of these documents serves a different purpose and is prepared at different phases of a clinical trial, they remain  interlinked. Therefore, if a prospective approach is applied while preparing one document, it can support the creation of the other documents at a later stage. This concept works by bridging the gap between various phases of clinical trial documentation and hence eliminating extraneous processes while retaining the essentials. In this paper, we will discuss the development of document connections while preparing material for internationally regulated disclosure and how to apply this information.