What is a Phase I Trial? <Return to Trial Phases> or <Return to Considerations and Decisions> 

Phase I Trials: These are the first studies of a potential new treatment in humans. Treatments which have shown some promise in the laboratory are introduced into a small number of patients, usually in the range of a dozen to a few dozen people. The study may take place in only one or a few cancer treatment centres. In a Phase I study, investigators are usually hoping to determine what is the best way to give a new drug (eg. by mouth, or by injection), how often to give it, and what dose to use. Investigators are interested in determining what side effects might occur. They may also be interested in finding out how the drug is handled or distributed in the body over time, usually by performing blood tests at set times. Safety features in Phase I trials