Clinical Development 301: Phase II/III

  • Course Price: $150 USD
  • BIO Member Price: $120 USD
  • Course Run Time: 55 minutes
  • Course Level: Level 3 - Advanced
  • Completion Period: 2 week

Clinical Development 301: Phase II/III begins by explaining the purpose and key differences between well-controlled Phase I, II, and III trials. This class considers the various trial design approaches, endpoint choices, statistical considerations, and special designations that speed up the FDA and EMA approval process. 

Suggested Prerequisites

Clinical Development 101: General Principles
Clinical Development 201: Phase I 

Takeaways
  1. Key differences between early stage (Phase I) and late-stage (Phase II/III) clinical trials.
  2. Regulatory significance of clinical endpoint, primary endpoint, secondary endpoint, surrogate endpoint.
  3. Fluency in Phase II and Phase III clinical trial nuances.
  4. Basic statistical analysis completed in late-stage trials.
  5. Description of specialized and expedited development cycles for rare disease, orphan drugs, and therapies for unmet medical needs.
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%
Download Agenda
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%
Trailer
Section 1: Phase II/III Introduction
Identifies the principle elements of a well-controlled Phase I/II clinical trial with an in-depth look at study design, endpoints, and statistical ana...More
Section 2: Phase II/III Objective and Design
Compares the general characteristics of Phase II and Phase III clinical trials. Defines pivotal study, adaptive trial, basket trial, and umbrella tria...More
Section 3: Phase II/III Special Designations
Focuses rare disease and serious unmet medical need designations in both the US and Europe. Explains the challenges with clinical studies associated w...More
Final Quiz
LinkedIn Certificate Demo
Certificate Requirements
  • View entire course 
  • Pass the course exam with a 70%