BOSTON, Nov. 2 (UPI) -- The risk of treatment-related or toxic death for U.S. cancer patients enrolled in phase 1 clinical drug trials has decreased during the past 12 years.
Researchers say with more products of the biotech industry reaching the clinical trial level, there are more than 550 phase 1 trials open to U.S. cancer patients at any given time.
During the initial phase of a clinical trial, the major objective is to characterize the agent's toxicity profile and to determine a dose and schedule appropriate for phase 2 testing, so patients who chose to participate may experience significant risks with limited benefits.
Dr. Thomas Roberts, Jr., of Massachusetts General Hospital and Harvard Medical School in Boston found the overall toxic death rate for 213 studies, involving 6,474 cancer patients was 0.54 percent, while the overall objective response rate was 3.8 percent.
Roberts said toxic death rates decreased from 1991 through 2002 from 1.1 percent during the first four years of the study (1991-1994) to 0.06 percent during the most recent four-year period (1999-2002).
The findings appear in Wednesday's Journal of the American Medical Association.
