Use of Historical Information in Clinical Trial Design
Sara Jimenez, PhD, MS
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 appropriate for their clinical trial design; Determine how to analyze endpoints and interpret results from clinical trials that use a historical control.
Using Historical Data to Transform Clinical Trials
Edward Bowen, MBA, MS
Head of Data Science and Solutions
GlaxoSmithKline, United States
Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study
Andrew Wilson, PhD, MS
Director, Pharmacoepidemiology and Statistics RWDS
PAREXEL, United States