Experts Unite to Improve Trials

"The investment in time, money, and human resources for clinical trials has been rapidly increasing in recent years, without a commensurate increase in the number of new products entering the market place. There is a growing consensus that clinical trials are inefficient and too costly."

So says Judith Kramer, MD, associate professor of medicine at Duke University Medical Center and executive director of the recently formed Clinical Trials Transformation Initiative (CTTI), a project designed to remedy the very problems she cited above.

CTTI was conceived by Duke University and the FDA in November 2007 as part of the FDA's Critical Path Initiative. The two organizations saw fit to establish a public–private partnership to help rethink the conduct of U.S.-based clinical trials.

"The CTTI will develop best practices and identify new methods to improve the quality of information derived from trials and make the research process more efficient, while continuing to ensure and strengthen the protection of trial participants," Kramer told Applied Clinical Trials. "As a broad-based coalition, CTTI will examine issues related to the clinical trial enterprise through projects that assess current practice, develop models for improvement, and evaluate these new models." Results of the project, she added, will be available in the public domain and well-communicated.

CTTI Executive Board Members

A Steering Committee will work together to propose specific projects and assemble project teams in accordance with priorities established by the Executive Board. Project ideas can be submitted by any interested party, and a submission form will soon be available on the CTTI Web site. The projects will then be evaluated and approved by the Executive Board, which is made up of 12 experts with roots in academia, biopharmaceutical companies, contract research organizations (CROs), FDA, the National Institutes of Health, patient organizations, and other stakeholders, who will oversee and guide the initiative.

One organization selected by the project founders to serve on the board is the Association of Clinical Research Organizations (ACRO), represented by Dr. Alberto Grignolo, corporate vice president and general manager of Parexel Consulting and a participant in ACRO initiatives since 2002, who will contribute to the initiative by sharing the CRO perspective on ACRO's behalf. Recognizing the increasing challenges in the development of new drugs, ACRO first took interest in the project with the announcement of the FDA and Duke's memorandum of understanding back in November.

"The CTTI aims to bring together leaders from across the research enterprise in a public–private partnership that has the potential to jump-start innovation in the design, conduct, and analysis of clinical trials," said Doug Peddicord, executive director of ACRO, to Applied Clinical Trials. "The cross-fertilization made possible by this collaboration among the best minds of industry, government, and academia promises exciting developments for the future."—Samantha Etkin

(For more information about CTTI, visit trialstransformation.org/)