Phase I clinical trials are also known as "first-in-human" trials. New drugs, therapies, and treatments must go through the three-step process of testing: phase I, II, and III.
The goal of a phase I clinical trial is to determine the best dose of a new drug, its side effects, and the types of cancer against which the new drug may work. The Food and Drug Administration (FDA) actively regulates phase I, II and III clinical trials to ensure patient safety and proper consenting guidelines are followed. Phase I trials are the most heavily regulated of the three clinical trials phases.
WHAT TO EXPECT
Patients participating in a phase I clinical trial begin by receiving a low dose of an experimental drug that has shown promising activity in preclinical testing. The drug's action and its effects are closely monitored through frequent blood and other diagnostic tests to determine the dose of the new drug that can be safely given.
As long as no severe side effects are noted, more participants will be asked to join the study to receive a higher dose of the drug. Increased doses will be given to each new group until the maximum tolerated dose is identified.