New IOM Report Urges Action to Repair a Clinical Trial System in ‘Crisis’

Authors of a new report, commissioned by the National Cancer Institute (NCI) and conducted by the Institute of Medicine (IOM) has found that inefficient management, overly complicated government oversight, and inadequate funding hamper the ability of the National Cancer Institute’s Clinical Trials Cooperative Group Program to design and run studies that properly answer critical questions about new therapies.

In a statement, study chair John Mendelsohn, MD, president of The University of Texas M. D. Anderson Cancer Center, said, “Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point and a few isolated or partial measures won’t suffice.”

The report, entitled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, identified four major goals:

• Improve the speed and efficiency of the design, launch, and conduct of clinical trials;

• Incorporate innovative science and trial design into cancer clinical trials;

• Improve prioritization, selection, support, and completion of cancer clinical trials; and

• Incentivize the participation of patients and physicians in cancer clinical trials.

The NCI Clinical Trials Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year. The American Society of Clinical Oncology (ASCO) urged NCI to double its support for the Cooperative within 5 years. NCI devotes about $145 million annually to the program, representing just 1.2 % of the Institute’s 2009 fiscal year budget of about $5 billion.

“Considering the program’s vital importance to the nation’s fight against cancer, it is clearly not in the public interest that it receives such a small fraction of NCI’s overall budget,” Richard Schilsky, MD, past president of ASCO, said in a statement.