BIO Professional Development
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Clinical Development 301: Phase II/III
Clinical Development 301: Phase II/III focuses on the purpose and critical differences between well-controlled Phase II and III studies. This class expertly explains the art of trial design and how each protocol measures efficacy via primary and secondary endpoints. Section two focuses on pharmacovigilance and the pivotal role of independent Data Safety Monitoring Boards who exhaustively review data to make critical recommendations about trial continuation, modification, or termination. Clinical Development 301 reveals the regulatory considerations of special designations that can accelerate the drug candidates' development. The class ends with an explanation of the New Drug Application (NDA) and Biologics License Application (BLA) that must be filed with and approved by the FDA to receive drug marketing approval. Join us to continue building your expertise in Clinical Development!
Takeaways
- Evaluate the purposes and key differences between Phase II and III clinical trials.
- Contrast the regulatory significance of clinical endpoints, primary endpoints, secondary endpoints, and surrogate endpoints.
- List the special designations that can accelerate the drug candidates' development
- Explain the basic statistical analysis completed in late-stage trials.
- State the critical role data safety monitoring boards play in patient safety.
Certificate Requirements
Complete the course quiz with a passing score of 75% or higher
Gain foundational knowledge on clinical development: trial conduct, design principles, GCPs, & trial phases I-IV.
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