NEWS TRENDS

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:

• Setting up national standards for a variety of research functions. This could include developing standardized electronic forms for data collection. This is needed because the current processes for starting and conducting clinical trials are too slow and complex.
• Changing the institutional review board model. In the current setup, companies are ill-equipped to avoid duplication effort at multisite trials.
• Introducing accreditation programs for clinical investigators and research sites. Right now it is cumbersome to verify the credentials of clinical researchers and research sites. A new system could work somewhat like a hospital accreditation program.
• Adopting electronic data management systems. This would enable researchers to track data in real time and spot trends more quickly. Also, if these systems were standardized, that would make it easier to compare data from different trials.

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.