Drug developers and global regulators are rapidly expanding the use of real-world evidence (RWE) to design, test, and review rare disease treatments, but knowledge gaps on the part of payers regarding the validity and value of RWE are limiting patients’ access to such breakthroughs in ways that should be tackled, according to a new […]
To the uninitiated, the term “advanced analytics” might sound a bit dry, but it holds exciting promise to make clinical trials far more efficient and deliver vital drugs and treatments to patients more quickly and safely, say a quartet of thought leaders with hands-on experience leveraging its benefits. “Advanced analytics can enable faster detection of […]
A new guidance from the U.S. Food and Drug Administration (FDA) offers the agency’s latest thinking on how industry should design, run, and handle data reporting when leveraging adaptive clinical trials. The final “Adaptive Designs for Clinical Trials of Drugs and Biologics” guidance is largely unchanged from its 2018 draft predecessor. The guidance also […]
Maybe it’s all that sunshine, but the value of certification in improving clinical trial workforce quality standards is clear to see in Florida, where the University of Florida’s (UF’s) Clinical and Translational Science Institute (CTSI) advocates, recognizes, and supports its personnel in attaining and maintaining the status of being a certified professional. As Allison Trainor, […]
Organizational barriers and silos—both real and imagined—hamper clinical trial performance in a number of ways. While some obstacles are probably inevitable given the complexity and breadth of conducting a trial, in some regrettable cases the industry gets in its own way with outmoded views and operating procedures. For example, the stale and arbitrary belief that […]
