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Clinical trials plan is held as a model

Dartmouth's Norris Cotton Cancer Center recently became one of just four cancer centers nationwide whose clinical trials protocols were held up as national models by the National Cancer Institute (NCI).

A final step in the approval of any promising new cancer treatment is a clinical trial, when researchers test a new drug or therapy on human patients. Of course, patient safety is the paramount concern in conducting such trials. The Norris Cotton Cancer Center's "Clinical Trials Safety and Monitoring Procedures" were posted on the NCI Web site in July as a model for other cancer centers nationwide. The other three institutions whose plans are also posted are Duke, the University of Wisconsin, and St. Jude's in Memphis, Tenn.

All four institutions' plans can be downloaded by going to www.cancer.gov/ClinicalTrials/conducting/dsm-example-plans.

"We place the highest priority on ensuring the safety of patients participating in clinical trials," explains Dartmouth oncologist Raymond Perez, M.D., director of the Phase I Clinical Trials Program at Norris Cotton. "Procedures to insure the safety and integrity of clinical trials, and development of newer, better cancer treatments, really go hand in hand."

This page on the National Cancer Institute's Web site lists as models the clinical trials protocols of four cancer centers—including Dartmouth's.

The strength of Dartmouth's plan, adds Priscilla West, director of Norris Cotton's Clinical Research Office, is that "it is concise and logical. . . . It establishes clear lines of oversight for all levels of research activity, from the nitty-gritty details of data collection to the broader issues of patient informed consent and patient safety. There is also an effective system of checks and balances, ensuring that patient safety issues do not fall through the cracks.

"The degree to which Dartmouth investigators and research staff are personally committed to patient safety and well-being" is another mark of distinction in West's book. Patient safety is "wholeheartedly supported at all levels," she says.


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