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Use of Historical Information in Clinical Trial Design
Session Chair(s)
Sara Jimenez, PhD
Mathematical Statistician, OB, OTS, CDER
FDA, United States
The use of historical controls in clinical trials may be an alternative method to assess the efficacy of a new drug. Challenges that arise from the use of historical controls, as well as methods for overcoming those challenges, will be discussed.
Learning Objective : Determine whether the use of a historical control is Determine whether the use of a historical control is appropriate for their clinical trial design; Discuss how to analyze endpoints and interpret results from clinical trials that use a historical control.
Speaker(s)
Efforts to Combine Data Across Companies
Edward Bowen
Transcelerate Biopharma, United States
Lead, Placebo as Standard of Care Workstream
Using Historical Data to Transform Clinical Trials: Statistical Considerations
Jessica Lim, MA
GlaxoSmithKline, United States
Director, Clinical Statistics
Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study
Andrew Wilson, PhD, MS
Parexel, United States
Head of Innovative RWD Analytics
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