How to Think Clinical Research

July 8, 2022 to August 5, 2022
1:00 pm

Simon Haroutounian, PhD

Session 1 – Friday, July 8, 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 22, 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 5, 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.