Full program description
This program is comprised of 5 courses and 1 panel discussion offering perspectives on clinical trial design from the pharmaceutical industry, U.S. Food and Drug Administration, and the regulatory consultation industry.
Clinical trials play a pivotal role in evaluating new interventions to prevent or treat disease in humans. The regulatory environment and strategy drive the development of drug and medical devices including design of clinical trials/programs. Topics include principles and methodologies used in study design, implementation, and analysis of clinical trials, ethical issues from medical device development, and an overview of the FDA’s evolution to become the nation’s leading authority for regulatory oversight.All study design elements including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III and Phase IV studies will also be explored.
Courses available in this program:
- Course 1: Key Regulatory Terminology in Clinical Trial Design
- Course 2: Evolution of FDA’s View of a Well-Designed Clinical Trial
- Course 3: Classical and Novel Designs Used in Regulatory Approvals
- Course 4: Unique Designs for Medical Device Trials
- Course 5: Case Studies and Future Trends
At the end of this program, participants will recognize different clinical study designs and their functions, identify scientific and practical issues associated with planning of a clinical research study, gain basic understanding of biostatistics and its relevance in design and analysis of clinical research, and understand the FDA’s impact on food and drug safety and various regulatory pathways to achieve clinical trial approval.