The Four Phases of FDA Clinical Trials

Clinical Trials pic

Clinical Trials

Headquartered in Greenwich, Connecticut, Great Point Partners began a growth recapitalization of portfolio company Alliance Biomedical Research (ABR) in September 2016. ABR conducts FDA clinical trials at 11 sites in the Southeastern United States.

Required for the marketing and distribution of prescription drugs, the FDA approval process takes place in four stages. Here is a quick overview of what each phase entails.

Phase I: Conducted with no more than 100 subjects, Phase I studies evaluate the pharmacology and safety of a drug. Dosage starts low and gradually scales up to assess the drug’s effects in the body.

Phase II: Drugs in this stage of the approval process are studied to determine their effectiveness in treating a specific disease. During this phase, researchers attempt to establish the effective dose, dosing interval, and method of delivery.

Phase III: Phase III studies take the findings from Phase II studies and expand them to a larger swath of the population, often recruiting many thousands of subjects. Results obtained during this phase have the sample size necessary to maximize statistical power.

Phase IV: Enacted after a drug has been brought to market, Phase IV studies assess the long-term effects of a drug or evaluate a drug’s suitability for off-label uses.