A 12-member Executive Board has been appointed to oversee the Clinical Trials Transformation Initiative (CTTI), the broad-based coalition established by the US Food and Drug Administration (FDA) and Duke University Medical Center last November.

Dr Robert Califf, vice-chancellor for clinical research at Duke University, and Dr Rachel Behrman, director of the FDA’s Office of Critical Path Programs, had already been named as co-chairs of the public-private partnership formed by the FDA and Duke University as the starting point for a cross-sector initiative to improve the quality and efficiency of clinical trials in the US.

They will carry over these roles to the Executive Board, whose initial tasks will include defining the CTTI’s strategy and prioritising areas for projects involving “research on research”.

The other board members cover the spectrum of government, industry (pharmaceutical, biotechnology, medical device and contract research), academia and patient advocacy interests. They are:

- Dr Susan Alpert, senior vice-president and chief quality and regulatory officer at Medtronic;

- Dr David DeMets, professor of biostatistics and medical informatics at the University of Wisconsin;

- Kenneth Getz, senior research fellow at the Tufts Center for the Study of Drug Development;

- Dr Glenn Gormley, senior vice-president, global clinical development and medical affairs at Novartis Pharmaceuticals Corporation;

- Dr Alberto Grignolo, corporate vice-president and general manager, drug development consulting at Parexel, representing the Association of Contract Research Organizations;

- Nancy Roach of the Colorectal Cancer Coalition (C3);

- Dr Jay Siegel, group president, research and development, biotechnology, immunology and oncology at Johnson & Johnson;

- Dr Lana Skirboll, associate director, science policy at the National Institutes of Health;

- Dr Robert Temple of the FDA’s Office of Medical Policy and Office of Drug Evaluation I;

- Dr Bram Zuckerman, director of the FDA’s Division of Cardiovascular Devices.

What is now known as the Clinical Trials Transformation Initiative was set up to address “growing frustration among patients, consumers, the academic community and industry over the difficulty of conducting high-quality clinical trials in a timely manner that could produce information physicians need to define optimal treatments for their patients”, Duke University noted.

Among the areas the CTTI has talked about exploring are establishing national standards to streamline current approaches to initiating and conducting clinical trials; alternative models for Institutional Review Boards to minimise duplication of effort in multisite clinical trials; identifying strategies to enhance the informed consent process; establishing accreditation programmes for clinical investigators and research sites; and expanding the use of technology to improve data management.

Dr. Judith Kramer, associate professor of medicine at Duke University, will serve as executive director of the coalition. She pointed out that the number of clinical trials conducted in the US had declined over the past ten years, with a fall of 30% since 2001.

“We are seeing discovery and innovation at a quickening pace, yet the US is perceived by many as a sluggish and inefficient environment for clinical research,” Dr Kramer commented. “As a result, an increasing number of clinical trials of products destined for the US are actually conducted offshore. We need to be able to conduct these trials here at home, because Americans are the target population for many of these products.”