NCI plans clinical trial system reforms

Change is afoot at the National Cancer Institute, and clinical trials may never be the same again. NCI is becoming more data focused in drug development, according to new leadership, and is taking the clinical trial bull by the horns in wrangling onerous administrative and tech tasks in cooperative trials.

Earlier this month, Harold Varmus was sworn in as 14th director of NCI. Varmus, who led NIH from 1993 to 1999, says that first on his list of reforms is the clinical trial system. He referenced a recent Institute of Medicine report that recommends restructuring and increased funding for NCI's Clinical Trials Cooperative Group Program.

"Everything we do and everything that we say will be based on evidence," says Varmus, according to NCI.

The wheels are already turning in a plan for a single, Internet-based system for data collection and management in cooperative, large-scale trials. Mayo Clinic biostatistician Daniel Sargent will take the helm at the Statistical Center for the Cancer and Leukemia Group B (CALGB), an NCI-funded national association. Sargent will be integrating statistical, data management and information technology functions at Duke University with those of the NCI-funded North Central Cancer Treatment Group and the American College of Surgeons Oncology Group. The goal is to overcome the unnecessary administrative and technical burdens of large-scale multi-institutional trials. Some 3,100 institutions in the U.S. contribute to such trials.

Sargent's purview will include a 90-member team at Mayo's three campuses and at Duke University.

- see the article
- here's the Medical News Today article
- and National Cancer Institute bulletin

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