Study of cancer trials finds significant safety improvement

The chance that patients participating in early-stage cancer research studies will die from the experimental treatments has dropped dramatically over the past decade, according to a study from the Massachusetts General Hospital (MGH) Cancer Center and the Massachusetts Institute of Technology (MIT). In an analysis of more than 200 Phase 1 research trials from 1991 through 2002, the researchers found that treatment-related deaths decreased by 90 percent during the study period. The report appears in the November 3 Journal of the American Medical Association.

"We undertook this study because there has been so much concern in recent years about the safety of clinical trials. We wanted to see if the increased attention to patient safety had made a difference and if the addition of targeted therapies, which tend to be less toxic, had also helped," says Thomas Roberts Jr., MD, of the MGH Cancer Center, the paper's lead author. "Now we can tell patients with cancer that, compared with 10 years ago, they can expect a higher level of safety when they enroll in early-stage clinical trials."

Representing the first time potential new drugs are tested in humans, phase 1 trials have a goal of assuring drug safety and determining the best dosage. While most of these early-stage studies enroll healthy volunteers, cancer studies have several important differences. Phase 1 cancer studies are usually restricted to patients with cancer who have exhausted established therapeutic options. While identifying toxic effects is the primary goal of most Phase 1 studies, cancer trials also have a secondary goal of evaluating anti-tumor effects.

Since there had been no comprehensive analysis of Phase 1 trials since the mid-1980s, the researchers compiled a database of Phase 1 trial results reported at the annual meeting of the American Society for Clinical Oncology from 1991 through 2002. In order to insure that the studies were comparable, the investigato

Contact: Sue McGreevey
Massachusetts General Hospital

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