Phase II-IIIb "Patient" Volunteer Studies

Patient volunteers in Phase II – IIIB studies have the condition the new drug is intended to treat. These studies are called “patient studies.” This differs from Phase I studies, which are generally conducted in healthy volunteers.

A patient volunteer is an adult with a known underlying medical condition. Patient participation helps determine:

• effectiveness of the medication against the disease
• doses required to achieve these effects

Although patient volunteers may or may not receive any therapeutic benefit from research participation, they will usually receive financial compensation for their time.