David Burrow

FDA Pushes Proactive Clinical Trial Quality Control

Protocol violations and faulty record-keeping habits continue to be among the most common problems uncovered by U.S. Food and Drug Administration (FDA) inspectors, says David Burrow, PharmD, JD, acting director of the Office of Scientific Investigations within the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. Burrow’s tip? Remember that “quality […]

Sparking Patient Recruitment with Better Explanation of Trial Benefits

Potential clinical trial subjects will be far more likely to participate if they are convinced doing so will benefit their overall health, says Jennifer Byrne, CEO of PMG Research. However, there must be action behind the words explaining trial-related concepts, she stresses. “Broadening the total value proposition of clinical research” needs to go beyond buzzwords, […]

ICH E6 (R2) Puts More Pressure on Quality Risk Management Plans

“Any risk management plan is going to be important, but even more so now because we have the ICH E6 revision [from the International Council for Harmonization] that explicitly calls for quality management” in the conduct of clinical trials, notes Deborah Rosenbaum, a clinical research consultant and trainer with Sarrison Clinical Research, llc. The ICH […]