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Course Agenda
Day 1 (8:30AM-4:00PM)

8:00 – 8:30 AM: Registration

8:30 – 10:00AM: Lecture 1: FDA’s guidance on Adaptive Design Clinical Trials
  • FDA acceptance of adaptive trials for Phase I-III trials
  • Current guidance documents from FDA and EMA
  • History of FDA review of adaptive trials
  • Pros and cons of adaptive design
  • Adaptive design for drugs, biologics and medical device trials

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Lecture 2: Clinical Trial Design for Adaptive Trials
  • Definitions and terminology related to adaptive clinical trial design
  • Benefits of the adaptive approach in defining and addressing trial objectives
  • How to recognize the characteristics of adaptive design protocols and ensure that adaptive features of a trial are adequately described
  • The importance of providing a complete prior specification of potential adaptations and decision rules in the protocol and/or consent form

12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Lecture 3: Bayesian Adaptive Trials for Medical Device and Pharmaceutical Trials – A Case Study
  • What is this thing called Bayes? Why Bayes?
  • Statistical principles for Baysian design
  • Baysian trials in medical devices
  • Baysian Adaptive clinical trials in cancer
  • Baysian trials & personalized medicine

2:15 – 2:30AM: Break

2:30 – 4:00PM: Lecture 4: Practical Challenges and Solutions in Adaptive Design Trials
  • Randomization techniques and challenges
  • Dynamic allocation in several predictors for interim analysis
  • Management of drug supplies in multicenter trials
  • Managing clinical sites for adaptive trials
  • Challenges with recruitment of patients for adaptive trials
Day 2 (8:30AM-4:00PM)

8:30 – 10:00AM: Lecture 5: Key Data Considerations for Successful Adaptive Trial Implementations
  • Designing a CRF for adaptive trials
  • Data collection and database buildup considerations
  • Data queries and resolutions
  • Practical tips for data management for adaptive trials

10:00 – 10:15AM: Break

10:15 – 12:00 noon: Lecture 6: Practical Tips for Writing an Adaptive Trial Protocol
  • Key elements of an adaptive protocol
  • Role of subject matter experts in study design
  • Comparison to non-adaptive protocols
  • Safety monitoring and clinical monitoring practices
 
12:00 – 12:45PM: Lunch

12:45 – 2:15PM: Lecture 7: Interim Analysis and Statistical Analysis Plan
  • Type of interim analysis
  • Number of interim analysis allowed and why
  • Statistical consideration for adaptive trials
  • Statistical analysis plan and simulations
  • Maintaining blinding and data integrity
 
2:15 – 2:30AM: Break

2:30 – 4:00PM: Lecture 8: Multi-national Adaptive Trials: Tips from Experts
  • Regulatory approval of adaptive trials by non-US and non-EU nations
  • Drug supply issues for multinational studies
  • Randomization challenges
  • Site management challenges
  • IRB review issues