NCI to overhaul clinical trials system

The National Cancer Institute (NCI) has announced plans for a major transformation of its Clinical Trials Cooperative Group Program, which conducts many of the nationwide trials for new cancer therapies. The nine groups currently conducting trials in adult cancer patients will be reorganized into four state-of-the-art entities that will design and improve trials of cancer therapies, according to a statement issued by the agency (www.nih.gov/news/health/dec2010/nci-23.htm).

The changes come in response to an April 2010 report from the Institute of Medicine (IOM), which was undertaken at the NCI's request. In that report, the IOM described the current trials system as inefficient, cumbersome, underfunded, and overly complex. “Improved treatments for cancer will be delayed and patient lives will be lost unnecessarily unless the efficiency and effectiveness of the clinical trials sys­tem improves,” charged the IOM (www.iom.edu/~/media/Files/Report Files/2010/A-National-Cancer-Clinical-Trials-System-for-the-21st-Century-Reinvigorating-the-NCI-Cooperative/NCI Cancer Clinical Trials 2010  Report Brief.pdf). “The implementation of the report's collective recommendations will reinvigorate the NCI Clinical Trials Cooperative Group Program and strengthen its position as a critical component of the translational pathway from scientific discov­ery to improved treatment outcomes for patients with cancer.”

The IOM cautioned that modifying any single element of the program or the clinical trials process would not suf­fice; rather, across-the-board changes were urgently needed.

In addition to consolidating the trial groups, the NCI will take several other steps to increase efficiency, such as imposing new deadlines to reduce by half the time to initiate new clinical studies, and terminating studies not begun within 2 years of concept approval. The agency has already succeeded in reducing the average time for final sign-off and approval on protocols for national trials from 150 days in 2007 to 42 days in 2010. A revamped review process will include advocates and professionals at cancer centers and will emphasize disease-specific and modality-specific oversight.

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