Phase II Clinical Trials
Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on groups typically ranging from 20 to 300. This phase is designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
Phase II studies are sometimes divided into Phase IIA and Phase IIB.
- Phase IIA is specifically designed to assess dosing requirements. that is, how much of the drug should be given.
- Phase IIB is specifically designed to study efficacy, that is, how well the drug works at the prescribed dose(s).
Some studies, however, combine Phase I trials and Phase II trials, and in the process test for both efficacy and toxicity.
Trial Design
Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.
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