This course identifies and discusses the basic concepts describing the design of clinical trials for demonstrating safety and efficacy for biologics, medical devices, or pharmaceutical products. It will identify, describe and discuss the similarities and differences of clinical trials between the various biomedical product segments. Students will identify and understand clinical trial nomenclature, key components of a clinical development plan and various options for the design of clinical trials. The life cycle and timeline for a clinical trial will be identified and understood.
- Design a Clinical Development Plan (CDP) to include the strategy and clinical development requirements for a new biologic, drug or medical device.
- Differentiate the role and types of contributions needed from regulatory, marketing, R/D and other functional areas to develop a clinical development plan.
- Develop key Go/No Go criteria to advance a new drug or medical device product from Phase 1 to Phase 2 to Phase 3.
- Select milestones and assumptions that describe the time course for conduct of a typical clinical trial.
Recommended: Prior completion of
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