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NETS - Phase II Clinical Trials (Safety, POCC, Dose)

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What are Phase II clinical trials and why are they important in drug development?

Phase II clinical trials are studies to evaluate the effectiveness of an investigational drug or therapy and observe short-term side effects and risks. They continue the study of drug safety and dose, and they also aim to provide proof of clinical concept (POCC) - that is, proof that the drug has the desired effect on individuals with a specific condition. This means that, unlike Phase I trials, Phase II trials include participants affected by the disease or condition of interest as opposed to the unaffected volunteers utilized in Phase I. Phase II clinical trials usually last around two years.

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