We will spend about 45 minutes providing a brief overview of the following 10 points (3-4 minutes per point). In the last 10-15 minutes, via a group discussion, we will identify a problem (suggested by students) that we want to address by performing a clinical trial.

Goal: Provide an overview of the thought process in designing a clinical study.

• Identification of a clinically meaningful problem
• Evaluation of the existing knowledge base about the problem
• Forming a hypothesis
• Testing a hypothesis in human subjects
• Brief overview of types of clinical studies
• Defining your primary outcome
• Determining your study design
• Rationale for determining inclusion and exclusion criteria
• Sample size and power
• Efficacy, effectiveness, toxicity and safety