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Understanding Clinical Trials

Researchers conduct clinical trials to test a new drug for treatment or prevention of disease. The process usually involves three phases of testing:

  • Phase I trials usually involve a small number of patients and are designed to evaluate safety and optimal dosing of a new drug.
  • Phase II trials further test a new drug’s safety and evaluate its efficacy.
  • Phase III trials involve a larger number of participants and compare new drugs to current standard treatments. Participants are usually randomly assigned to the group receiving standard treatment or the group receiving the new treatment. Phase III cancer treatment trials do not include a placebo arm (unless there is no standard treatment for that particular cancer). Placebo arms may be included in chemoprevention trials studying drugs that might lower cancer risk in people who do not already have the disease.

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