What are the different phases of a clinical trial?
• Pilot Study A pilot study is a first look to test an idea. It usually involves one or a very small number of participants. Because it is so early in the development of the idea, there is very little specific information for the participants and very careful observations are required. These studies are designed to be completed in a short period of time. • Phase I Study Focus is on safety in humans, and it usually lasts from 6 to 12 months. The study involves initial administration of an investigational drug to a small number of participants to determine the safe dose range for the drug. Observations are made regarding how the drug is absorbed, metabolized, eliminated and to test for obvious side-effects. Some evidence of the drug’ potential effectiveness may also be obtained. Phase I studies may be performed on healthy volunteers, or on patients with the specific disease the drug is intended to treat. • Phase II Study The clinical administration of a new drug to a limited number of pa
