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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)
Edward Bowen
Lead, Placebo as Standard of Care Workstream, Transcelerate Biopharma, United States
Jessica Lim, MA
Director, Clinical Statistics, GlaxoSmithKline, United States
Andrew Wilson, PHD, MS
Head of Innovative RWD Analytics, Parexel, United States
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