THOUGHT LEADERSHIP

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.

At PROMETRIKA, we provide biostatistical analysis and regulatory medical writing services to our sponsor companies who have reached the stage of New Drug Application (NDA) or Biologic Licensing Application (BLA) preparation. One of the many crucial documents in these applications is the Package Insert (a.k.a., Prescribing Information or Product Information; PI), the summary of safety and efficacy data on proposed new drugs and biopharmaceuticals (‘drug’ will be used to refer to both hereafter). In the following discussion, I will trace the source and distillation of the efficacy data presented in the PI.

This year, PROMETRIKA team members have attended many industry conferences in which the hot topics always seem to be AI and automation of processes. Of course, the innovation cool crowd is excited to jump on board. What has really piqued my attention are the discussions amongst technology vendors about automating SDTM mapping. PROMETRIKA, as a full-service CRO, has a strong focus on biostatistics, statistical, and SDTM programming. Since SDTM mapping is a major part of the programming work that we do, I asked myself “Do we need a new business model for automating SDTM programming?” After hearing multiple viewpoints on the subject, I’ve come away with a list of pros and cons of automating SDTM mapping.

Throughout the 17 years that PROMETRIKA has offered Clinical Operations services, our goals have been to streamline and maximize efficiency in clinical trials and provide trial management transparency to our sponsors. We have steadily enhanced and integrated our trial data collection and management systems to achieve a fully integrated platform that will provide seamless coordination of EDC, CTMS, and eTMF data.

As a CDISC Platinum Member, PROMETRIKA has the opportunity to sit on the CDISC Advisory Council (CAC), which plays an important role in shaping CDISC’s development and direction. Platinum Member representatives serve on the CAC, contributing industry expertise and sharing real-world implementation experiences. The CAC represents a cross-section of organizations within the pharma industry; thus, making them a part of the review process for assessing and revising standards. Collectively, the CAC provides the CDISC Executive Team with recommendations that further the CAC mission of “unifying the voices of membership to influence and support CDISC goals.”