Phase II Clinical Trials

What Is a Phase II Clinical Trial?

Phase II of the clinical trials involves further testing of the new drug candidate to a larger group of participants (typically a few hundred) with the disease/condition of interest to evaluate effectiveness. This phase aims to assess efficacy and to collect further safety data.

Learning Objectives

• Discuss the goals of a Phase II study
• Describe the study design of a Phase II trial
• Define Phase IIa and Phase IIb of Phase II clinical trials