THOUGHT LEADERSHIP

Building a robust and efficient electronic data capture system (EDC) for today’s complex clinical trials is a major undertaking. The elements of the EDC must be carefully planned, the programming must be succinct, and the risks to data integrity must be considered. Clearly, these crucial requirements demand careful thought and can be time-consuming. An option for the timely initiation of a trial may be to split the release (a.k.a., the “go-live”) of EDC elements in a controlled and considered manner. PROMETRIKA’s Data Management team has extensive experience with planning and executing successful split-release EDCs.

The PROMETRIKA team attended the Fierce Biotech Week conference, which offered a front row seat to the evolving landscape of clinical research, where innovation is not just a buzzword but a driving force. The conversations centered around the growing adoption of Risk-Based Quality Management (RBQM) and the ongoing evolution of the Trial Master File (TMF) as a critical tool for inspection readiness. These topics not only dominated sessions and panels, they sparked dynamic roundtable discussions, signaling a shift in how the industry is approaching trial efficiency, compliance and data integrity.

The win ratio, introduced by S. Pocock in 2012, is an alternative and practical approach for analyzing composite endpoints. It was originally designed to address challenges faced in cardiovascular (CV) trials, but over the years the win ratio has been utilized in multiple therapeutic areas.

CDISC standards in clinical trials are the cornerstone of any successful submission to regulatory agencies. While they are “standards,” the structure and the nuances of applying them are continually evolving and changing, making it important to keep up to date in order to provide quality submissions. Here at PROMETRIKA, a full-service CRO, our statistical programmers and biostatisticians engage in continuing education activities by attending webinars, conferences, and training sessions specifically related to CDISC standards in clinical trials.

Recently, while performing CDISC SDTM mapping for one of our clients, a unique situation arose that involved the DA (Drug Accountability) domain.  This domain tabulates the amount of treatment units dispensed to a subject and the amount returned to gauge dosing compliance for each treated subject and is often collected in a log format.  On the surface, it seems like a fairly straight forward domain, but for this particular example, there were a number of factors that contributed to creating a complex scenario.