prostate cancer treatment trial
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What is a Phase III clinical trial?
As you may know, it is not easy for a new drug to reach the market. The Food & Drug Administration (FDA) requires pharmaceutical manufacturers to undertake rigorous, closely-supervised testing to conclusively demonstrate both the safety and efficacy of any new therapy before a drug is approved for widespread use. These tests are called clinical trials, and are conducted in three phases:
Phase 1 tests a new potential drug or treatment in a small group of patients for safety.
Phase 2 involves a larger test group of similar subjects. If these first two are successful, Phase 3 expands the studies to an even larger group of people, and if the drug successfully passes, it is usually approved.
To ensure reliability of results and avoid the possibility of bias in assessing the treatments effectiveness, many Phase III drug trials are designed as "randomized," double blind, and placebo-controlled. This means that each participant is randomly selected to receive either the study treatment or a placebo (a harmless, inactive pill, liquid, or powder that has no therapeutic value). To avoid potential for bias during the study, neither the subject nor the administering physicians know which treatment each subject is receiving. While a new treatment approach is being tested in a study like the one you are being offered, no aspect of care is excluded - all participants receive the same standard of care as a patient who is not participating in the study.