Curing cancer trials

NCI cancer trial cooperatives urgently need repair; cures are controversial

A study reported this month in the Journal of the American Medical Association challenges the standard practice of removing cancerous lymph nodes from the underarms of women with breast cancer. For patients, its finding represents the best of what the NCI's Clinical Trials Cooperative Groups can be.

The flip side is the snail's pace at which the cooperative system works, which means many trials never finish, or are irrelevant by the time they do.

There is broad agreement the cooperative groups must start studies faster, and and NCI already has implemented changes designed to do just that.

But that is about where the consensus ends.

Illustrating the best of the cooperative system, the Z0011 trial published this month by the American College of Surgeons Oncology Group (ACOSOG) showed sentinel lymph node dissection (SLND) is noninferior to complete axillary lymph node dissection (ALND) on survival in women with some types of breast cancer.

The study thus could spare thousands of women each year from the complications of ALND, including infection and lymphedema, improving quality of life without shortening its length.

For more than 50 years, the cooperative groups have helped define the practice of oncology. Their landmark studies have directed physicians to the most effective drug combinations, spared patients unnecessary invasive surgeries, optimized the use of radiation and other interventions and improved prevention and diagnosis (see "Understanding the Co-ops," A7).

Yet last April, the Institute of Medicine said the cooperative group program is "approaching a state of crisis." According to the report, which was commissioned by NCI, inefficiencies and lack of funding threaten the program's continued ability to conduct the kinds of large-scale, innovative trials needed to advance patient care.

As a result of a complex system of oversight, the median time required to design, approve and activate a Phase III trial is 2.5 years. Because of these delays, a large proportion of studies go unfinished, often because the questions they were designed to answer became irrelevant.

Only 60% of trials begun by cooperative groups are completed and published.

Furthermore, between fiscal 2002 and FY08, funding for the program decreased by 20% after adjusting for inflation. Meanwhile, knowledge of the molecular changes underpinning cancer and the use of predictive biomarkers are increasing the complexity and cost of cancer studies.

IOM and NCI say consolidating the cooperative groups' operations and requiring them to compete for funding will make the program more efficient, while ensuring continued competition for the best ideas. IOM recommended, and NCI has agreed, that the nine existing cooperative groups focused on adult cancers must be reduced in number.

But some clinical researchers, industry stakeholders and members of

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