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Clinical trials required to achieve drug approval are broadly organized into three phases – phase I, phase II, and phase III. Each phase has its own specific activities. Let’s walk through each of these phases and what happens during them. In phase I, the compound is studied in tens of healthy volunteers. Healthy volunteers? That seems like a strange way to test a potential drug. Well, during phase I the emphasis includes safety, tolerability, and pharmacokinetics (which is how the drug flows through the body) but not whether the compound works. For phase II, the compound is now tested in tens to hundreds of patients. While safety and pharmacokinetics are still studied, now the test subjects have a disease, and the study also monitors whether the compound works – the efficacy of the drug. Phase IIa trials look for evidence of efficacy, and phase IIb trials focus on the ideal dose for achieving efficacy. Phase III trials can include hundreds or thousands of patients with a focus on safety and efficacy in a broad pool of patients. Phase III trials are sometimes called “pivotal trials”. Emphasis is placed on risk and benefit of the compound and how it performs relative to the standard of care for the disease.

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