Program Description
Knowing how to effectively develop a clinical trial can get you started in research or take your research to the next level. Recognized as the gold standard in research study design, clinical trials help researchers learn about disease and improve health care for people in the future. This workshop covers the development, conduct, and interpretation of clinical trials.
Topics include principles and practical features such as choice of experimental design, choice of controls, sample size determination, adverse event monitoring, research ethics, informed consent, data management and analytic issues. Participants work in groups to design a clinical trial and develop a clinical protocol on a research question. Homework will be assigned between workshop meetings.
Competencies
Participants will learn to:
- Describe basic study designs for clinical trials, including limitations inherent in each design;
- Identify methodological and practical issues involved with the planning and implementation of a clinical trial;
- List requirements for protection of human research subjects, and apply these to clinical trials;
- Recognize and apply regulatory requirements for clinical research (particularly requirements of the Food and Drug Administration).
Intended Audience
Individuals who are interested in working in clinical research and those individuals already working in clinical research who wish to learn more about clinical trials.
Required knowledge/pre-requisites
No prior knowledge is needed.
