The team, led by Robert Califf, will create new standards for clinical trials.
FDA and Duke University Medical Center (Durham, NC) have begun a collaboration whose results could change how clinical trials for medical devices and drugs are conducted.
The collaboration will establish a public-private partnership with representatives from industry, academia, government, professional societies, and patient advocacy groups. This group will be charged with coming up with new standards for trials. It will also be asked to recommend methods and technologies that make trials safer, elicit better information from them, and produce a more efficient research process.
The collaboration is an outgrowth of FDA's Critical Path program, which seeks to make clinical research a less cumbersome process, so that medical devices and other regulated products can ultimately get to market more quickly. Robert Califf, MD, Duke's vice chancellor for clinical research, will chair the partnership. The cochair will be Rachel Behrman, MD, director of FDA's Office of Critical Path Programs.
The initiative will explore several ideas, including:
The initiative will start by trying to solve simple issues for which there is consensus, before moving on to tougher topics. It will take several years to complete.