THOUGHT LEADERSHIP

Maybe you’ve heard of it before. Another string of letters in the alphabet soup of clinical trials - an IDMC - sometimes also called just a DMC and other times a DSMB. But what does it stand for, what is it, and more importantly, do you need one?

Clinical trials are rapidly evolving and becoming more complex as they continue to adopt novel technologies and approaches. Factors such as the number of sites and countries involved, study phase, indication, design, procedures, and the number of data sources and data points collected contribute to this complexity, imposing a strain on study execution. Furthermore, in recent years, the biopharmaceutical industry has witnessed changes in business practices and an increase in merger and acquisition activity.

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.

January marks the time to develop goals for the upcoming year, and for 2023, I wanted to create a goal outside of project work and pursue individual career development. I became aware of the Certified Clinical Data Manager (CCDM®) program/exam.

Data Management (DM) and Clinical Operational teams must work hand in hand to properly execute the capture, management, and monitoring of clinical data throughout the entire life cycle of a study; however, the use of different systems, processes, and datasets makes close and effective collaboration a challenge.