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