戻る Agenda
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
Lead, Placebo as Standard of Care Workstream, Transcelerate Biopharma, United States
Using Historical Data to Transform Clinical Trials: Statistical Considerations
Jessica Lim, MA
Director, Clinical Statistics, GlaxoSmithKline, United States
Converging Lines of Evidence: Using Modern Structural Meta-analysis to Advance Multisite Knowledge Discovery - A Case Study
Andrew Wilson, PhD, MS
Head of Innovative RWD Analytics, Parexel, United States