Harness Advanced Analytics to Speed, Improve Clinical Trials

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 […]

FDA Headquarters

FDA Offers Guidance on Adaptive Clinical Trials

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 […]

Certification Powers Higher Level of Clinical Trial Performance in Florida

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, […]

Is it Time to Reexamine the Barriers Between Drug and Device Trials?

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 […]