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Steps Urged to Revitalize Clinical Trial Network

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A clinical trial network funded by the National Cancer Institute has contributed to major advances in cancer treatment over the last 50 years, but needs an overhaul to keep pace in the 21st century.

That's the verdict of an extensive evaluation of the NCI's Clinical Trials Cooperative Group Program. The 10 cooperative groups comprise more than 3,000 institutions and 14,000 investigators who enroll 25,000 people in cancer clinical trials annually.

"Cooperative groups fulfill an important role by conducting large-scale clinical trials of topics that aren't priorities for industry," says MD Anderson President John Mendelsohn, M.D., who led the review. "The problem is that the cooperative groups have become very inefficient, which is frustrating for everybody."

Cooperative group trials, for example, compare the effectiveness of existing drugs, test combination therapies and address rare cancers that otherwise might be ignored.  

Mendelsohn chairs study committee

The NCI requested the review by the Institute of Medicine of the National Academy of Sciences. Mendelsohn, an IOM member, chaired the study committee, which released its report in April. Since then, Mendelsohn has presented the recommendations to the American Association for Cancer Research annual meeting and The New York Times editorial page endorsed the report.

Donald Berry, Ph.D., professor and head of MD Anderson's Division of Quantitative Sciences, also served on the committee.

The IOM report lists 58 cooperative group clinical trial contributions to major advances in cancer treatment, including an increase in the cure rate for pediatric leukemia patients from 10% to 80% and the shift to less disfiguring surgery for breast cancer.

The multi-institutional nature of the groups leads to a complex network of reviews and approvals that cause delays, according to the report.

The median time from approval of concept to the launching of a Phase III clinical trial is two years, with a range of 1.25 to 7 years. Trials that launch late often have trouble recruiting participants and sometimes never finish. Only 60% of NCI-funded Phase III clinical trials are completed.

In one case, starting a clinical trial involved more than 800 process steps and 68 review loops -- instances where a change in the protocol, even a minor one, made by one review committee required the plan to be returned to previous reviewers.



Report recommendations
Among the report's recommendations are to:

•    Consolidate administrative and support functions, currently redundant in all 10 cooperative groups, based on a rigorous comparison of relative performance.

•    Eliminate clinical trial sites that enroll few patients or provide inadequate data.

•    Terminate trials that don't open within a set time -- two years for Phase III trials, for example.

•    Shift NCI's role from an emphasis on oversight to one of facilitation and support for high-quality clinical trials.

•    Increase reimbursement of clinicians for managing each patient in a trial and pay for their work designing and planning clinical trials. NCI reimbursement per case has been frozen since 1999 at $2,000, while actual costs run $4,500 to $6,000 per patient.

•    Give greater weight to cooperative group participation for clinicians in tenure and promotion decisions at academic institutions.

•    Push private and public health plans to cover the cost of non-experimental treatment in clinical trials. Many don't now, discouraging patients from enrolling.

•    Increase NCI funding by allocating a greater percentage of its budget to the cooperative group program to raise reimbursement to $4,000 to $6,000 per case. At $145 million a year, the program accounts for 3% of the NCI budget.

This is particularly important because clinical trials are becoming more complex as they focus on therapies tailored to the molecular aspects of a patient's tumor and the discovery of tumor biomarkers to guide treatment. Group trials need to make optimal use of scientific innovation.

"If adequate funding is not available, then the total number of cooperative trials should be reduced," Mendelsohn says. "This was our hardest recommendation to write. It's strong medicine, but we will have no other choice if we are to fully support high-quality clinical trials."

A print version of "A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program" can be ordered at the IOM website; an online version may be viewed free of charge.

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