There is a need to better understand the average cost of these sophisticated and multifaceted clinical trials, the factors driving such costs, and the drug development costs potentially saved by obtaining answers (positive or negative) more rapidly. More exploration of alternative funding approaches is needed, including more public–private collaborations among academia, pharmaceutical and biotechnology companies, and government agencies. The fourth session of the conference explored these issues with presentations by Robert Comis of the Coalition of National Cancer Cooperative Groups, Kevin Schulman of Duke University Medical School, and Gwen Fyfe of Genentech.

Dr. Comis began by noting that for Cooperative Group-funded oncology studies,12 the overall per-patient cost is about $6,000, of which only $2,000 is reimbursed by government grants (The Lewin Group, 2005). In contrast, one study of four companies found that the per-patient costs for industry-sponsored studies ranged from $60,000 to $85,000 for Phase III studies (of which about $15,000 to $18,000 is reimbursed), and from $46,000 to $85,000 for Phase II studies (of which $20,000 to $25,000 is reimbursed). It is generally much less expensive to conduct a clinical trial in a foreign country, with the costs of certain cancer clinical trials in Western Europe being nearly half the cost of the same trial conducted in the United States.13

Regulatory Costs

Prepatient start-up costs account for a significant portion of clinical trial costs, Dr. Comis said. For publicly sponsored Phase II or III studies, these costs are about $5,000, and about $8,000 for privately sponsored studies (The Lewin Group, 2005). Much of this cost is due to addressing regulatory requirements of various institutional review boards (IRBs) and government agencies, Dr. Comis and Dr. Schulman pointed out. Of nine functional steps identified for the conduct of high-quality trials, six include elements

12

The Clinical Trials Cooperative Group Program, which is sponsored by the NCI, is designed to promote and support clinical trials of new cancer treatments, explore methods of cancer prevention and early detection, and study quality-of-life issues and rehabilitation during and after treatment. Cooperative groups include researchers, cancer centers, and community physicians throughout the United States, Canada, and Europe. They work with the NCI to identify important questions in cancer research and to design clinical trials to answer these questions.

13

TrialSpace Grants Manager (see http://www.fasttracksystems.net/grantsmanager_products.php).



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