What Your Doctor May Not Tell You About(TM) Prostate Cancer by Glenn J. Bubley

Author:Glenn J. Bubley [BUBLEY, GLENN]
Language: eng
Format: epub
ISBN: 9780446536684
Publisher: Grand Central Publishing
Published: 0101-01-01T00:00:00+00:00

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Phase I Trials

Phase I trials evaluate how a new drug should be administered (by mouth, injected into the blood, or injected into the muscle), how often it should be given, and what dose is safe. Phase I studies, also known as safety studies, generally involve ten to one hundred healthy volunteers or patients and last for several months. The purposes of Phase I trials are to determine what is the maximum tolerated dose, what a safe dose is for patients, and what side effects might be expected. Also, sometimes the rates of metabolism of the test agent are assessed.

During this part of the trial, patients receive drugs at doses that range from ineffective to potentially excessive. The patients are divided into smaller groups, called cohorts. Each cohort is treated with an incremental dose of the new therapy or technique. The highest dose with an acceptable level of side effects is determined to be appropriate for further testing. About 70 percent of experimental drugs pass this initial phase of testing.

Many people who participate in Phase I trials do not understand why they are participating. Even when the risks and benefits are clearly spelled out in the consent forms, many patients do not understand that they may not benefit from a Phase I trial. In truth, only a small percentage of people in Phase I trials benefit directly from the drug they are testing. However, a 1995 University of Chicago study revealed that when asked about why they participated in a Phase I cancer trial, 85 percent of patients answered that they expected “possible therapeutic benefit.”

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