Tuesday, September 30, 2014

The Three Clinical Phases of Drug Discovery

Clinical trials represent some of the most important and widely recognized stages of the drug discovery process. Here is a quick look at the three primary stages of clinical trials.

Phase 1: Phase 1 clinical trials involve the first human testing in the entire life cycle of a potential drug. The trials occur in a small group of healthy volunteers and typically address questions involving absorption into the body, metabolism of the substance, and the presence of side effects.

Phase 2: After a drug passes through Phase 1, researchers expand clinical trials to include a small group of patients with the disease or condition in question. In Phase 2 clinical trials, scientists gather valuable data on the efficacy of the drug, the mechanism by which it proceeds, and the optimal dosage and scheduling.

Phase 3: In the final stage of clinical trials, researchers again expand the study to include anywhere between 1,000 and 5,000 patients. In Phase 3 trials, researchers conduct further investigation of safety and efficacy and hone in on appropriate labeling for the compound.