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NCI trials overhaul eyes community-based biomarker studies

Nearly 3 years after tasking themselves with overhauling the nation’s publicly funded cancer clinical trials system, which had been criticized as sluggish and unwieldy, researchers working for and with the National Cancer Institute are reporting a number of important successes.

The time between concept and activation of phase II trials sponsored by NCI has shrunk by more than a third, the researchers revealed at a 2-day workshop held this month in Washington. Time to activation for phase III trials has been halved since the overhaul process began.

Dr. James Doroshow


Dr. James H. Doroshow of the NCI’s Division of Cancer Treatment and Diagnosis in Bethesda, Md., said that trial opening times would continue to shrink, with an ideal lag of between 6 and 7 months for early phase trials, compared to more than 2 years in the past.

But Dr. Doroshow and other presenters also acknowledged that the overhaul is a work in progress, with serious challenges remaining. Prominent among these, said workshop chair Monica Bertagnolli of the Dana-Farber Cancer Institute in Boston, is "maintaining the integration of the community centers into the research network" as NCI’s scientific emphasis shifts quickly from large phase III trials to smaller, biomarker-driven phase II trials. The trials cannot succeed without broad participation in cutting-edge trials at the community level.

The workshop was sponsored by the American Society for Clinical Oncology and presented by the Institute of Medicine, which had commissioned a 2010 report demanding critical changes to the NCI’s clinical trials cooperative group program. The report described the program as "approaching a state of crisis," and recommended that it streamline its bureaucracy, speed activation and improve completion rates of its trials, emphasize innovative biomarker-driven science, and increase reimbursement per patient for trial participation.

The program has since undergone a restructuring to reduce its 10 cooperative groups to 5, including 1 pediatric group. It has created common enrollment and data management systems to be used by all 3,100 affiliated community and research institutions. It standardized its agreements for industry collaborations, launched a review process for grading the quality of its trials, and is in the process of creating integrated biospecimen banks, among other accomplishments reported by NCI’s Dr. Doroshow.

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