Simon Haroutounian, PhD
Session 1 – Friday, July 7, 1-3 PM (CSRB NTA room 401, 4th floor)
Goal: Provide an overview of the thought process in designing a clinical study.
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.
- Identification of a clinically meaningful problem
- Evaluation of the existing knowledge base about the problem
- Forming a hypothesis
- Testing a hypothesis in human subjects
- A 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
Session 2 – Friday, July 21, 1-3 PM (CSRB NTA room 401, 4th floor)
Goal: Familiarize students with the components of a clinical research protocol.
Based on the theme selected in session #1, and the 10 bullet points we discussed, we will put together a mock clinical study protocol, and discuss its different components.
Session 3 – Friday, August 4, 1-3 PM (CSRB NTA room 401, 4th floor)
Goal: Provide students with fundamental information of processes involved in clinical research.
We will use the protocol draft developed in the prior session to discuss the actual technical components of running a clinical study such as recruitment, informed consent, collection of clinical data, patient-reported outcomes, data analysis, interpretation, and manuscript preparation.