Monday, November 1, 2010 (Last Updated: 11/02/2010)
MONDAY, Nov. 1 (HealthDay News) -- Most recent oncology randomized controlled trials evaluate drugs that are available "off-protocol therapy" in the United States, and this can adversely impact trial enrollment, according to a study published online Oct. 25 in the Journal of Clinical Oncology.
Erika P. Hamilton, M.D., of Duke University in Durham, N.C., and colleagues searched the medical literature from 2006 to 2008 for reports on phase III medical oncology clinical trials, and used U.S. Food and Drug Administration approval data to determine the availability of the therapies outside of clinical trials (off-protocol therapy).
The researchers found that, among the 172 trial reports reviewed, 108 trials (63 percent) evaluated drugs that were available for off-protocol therapy at the start of the trial, while the investigational drugs became available for off-protocol therapy during an additional 19 trials (11 percent). For the trials at U.S. sites, time to accrual was longer (41 versus 22 months) and not as efficient (8.8 versus 22.7 patients per month) when off-protocol therapies were available. Furthermore, although 47 percent of experimental therapies proved superior for at least one major clinical outcome and 27 percent improved survival, 66 percent of trials reported at least one serious toxicity.
"Off-protocol availability of experimental drugs raises questions regarding patient safety, informed consent to treatment, and accrual to clinical trials," the authors write.
Hematology & Oncology
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