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Session 6: Advanced Statistical Methods to Borrow External Information
Session Chair(s)
Jerald Schindler, DrPH
Chief Executive Officer
Strategic Statistics, United States
Xiang Ling, PhD
Statistician
FDA, United States
External Information is incorporated into the statistical analysis of clinical trials in various settings. For example, trials for rare diseases may leverage external data to improve the study power with smaller sample size and oncology trials may use external controls for ethical consideration. Borrowing external information has been mostly used in early phases drug development and has increased usage in phase III trials protocols in recent years. This session will focus on considerations for using external patient-level data in late phase randomized clinical trials to improve statistical power. An overview of advanced statistical methods will be presented and application in clinical trials designs will be discussed through clinical case studies and simulation studies.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe the general ideas of various methods to borrow information from external data
- Explain the assumptions these approaches make
- Discuss the considerations of the potential applications in regulatory clinical trials
Speaker(s)
Streamlining Randomized Clinical Trials for Device Therapies in Heart Failure: Bayesian Borrowing of External Data : Ben Saville, PhD
Berry Consultants, United States
Speaker: Robert Abugov, PhD, MPH, MS
Mathematical Statistician
FDA, United States
Speaker: Roberto Crackel, PhD, MS
Mathmatical Statistician
FDA, United States
Speaker: Yoonhee Kim, PhD
Lead Mathematical Statistician
FDA, United States
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