Duke Partners with FDA to Modernize Clinical Trials

Nov 29, 2007
By Pharmaceutical Executive Editors

FDA and Duke University, last week, announced a strategic collaboration that will examine all the new tools developed for clinical trials and determine what the best strategy will be to advance and modernize the way pharma companies run trials.

Duke will host the partnership, which will include constituents from all facets of the clinical trial process, including patients, physicians, and pharma companies.

This ambitious collaboration is part of FDA's overall Critical Path program, which looks at how pharma companies can develop drugs in a smarter, more practical way. The clinical trials model was conceived in the late 1960s and is outdated compared with the multinational trials that large pharma companies are working with today.

According to a release, the group will examine establishing national standards for a wide range of research functions, explore alternative models for Institutional Review Boards, establish accreditation programs for both clinical investigators and research sites, and extend the use of technology to improve data management.

"The Critical Path is an effort to modernize medical-product development and the use of those medical practices in the healthcare system," said Rachel Behrman, director of the office of Critical Path programs at FDA. "If things don't evolve, they become antiquated. If no one makes sure these systems are current, they will not be as effective or efficient as they could be."

The partnership will pay close attention to the new technologies available, particularly electronic data capture and transfer. It also will look into how data is archived and how to move away from paper-based trial systems. "We no longer live in a paper-based world, yet the clinical trial system hasn't fully exploited those opportunities," Behrman told Pharm Exec on Wednesday. "Rules written for paper-based systems just don't work; they need to be looked at again. And the goal of the rules, which is to create an audit trail, has to be preserved, but it has to be done most appropriately for an electronic system."

FDA felt that collaboration would bring together the many constituencies involved in clinical trials to determine areas that need to be improved or completely redesigned.

Behrman made it clear that this partnership is solely a group of experts getting together to try to modernize the system. It is not an advisory panel or a standards-setting body.

"We believe this partnership should be organized by an entity that understands clinical trials inside and out, and it's their passion," Behrman said about Duke. "However, to be successful, this consortium will have to engage a broad spectrum of all constituencies—many academic organizations will be involved."

The first order of business will be to form an executive committee, which will take place in the near future.

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