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Activity Number: 75 - Clinical Trial Design-1
Type: Contributed
Date/Time: Sunday, July 29, 2018 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #330934
Title: Sample Size and Power Calculation for Immuno-Oncology Clinical Trials
Author(s): Binbing Yu* and Dongyue FU and Hefei (Harry) Yang
Companies: MedImmune, Inc. and MedImmune, Inc. and MedImmune, Inc.
Keywords: Cure; Delayed response; Immuno-oncology; Log-rank test; Non-proportional hazards

Long-term survival and delayed treatment effect are present in immuno-oncology (I-O) clinical trials, which violates the assumption of proportional hazards (PH). Therefore, the commonly used sample size and power formula derived under the PH model may not be proper to design an I-O clinical trial in the presence of both long-term survivors (cure) and delayed treatment effect. Ignoring the delayed treatment effect and cure fraction may lead to either under or over powered studies. We explore the proper sample size and power calculation methods for typical I-O clinical trials.

Authors who are presenting talks have a * after their name.

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