DIA/FDA Biostatistics Industry and Regulator Forum

Session Chair(s)

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)