Abstract Number:
3269
Submission Type:
Contributed Abstract
Contributed Abstract Type:
Speed
Participants:
Apurva Bhingare (1), Prabhu Bhagavatheeswaran (1), Jixian Wang (1), Ram Tiwari (1)
Institutions:
(1) Bristol Myers Squibb, Princeton, NJ
Co-Author(s):
First Author:
Presenting Author:
Abstract Text:
In oncology clinical trials, Overall Response Rate (ORR) is often analyzed either as primary or key secondary endpoint. Particularly, durability of response is of interest. As such, Duration if Response (DOR) and Time to Response (TTR) provide supportive information to assess Best Overall Response (BOR). Conventional Analyses of Duration of Response (DOR) is summarized for responders only. Descriptive statistics based on Kaplan-Meier Curves constructed with censored observations from the responders are used to summarize the DOR data. Alternative methods that utilize data from all patients randomized to the study treatments are becoming popular in literature (Huang et al., Annals of Internal Medicine 2020; Huang & Tian, Pharmaceutical Statistics 2022; Weber et al., Pharmaceutical Statistics 2023). These methods are based on mean (expected) duration of a patient being in response. The objective of this presentation is to explore different methodologies to analyze DOR data, to evaluate and compare the performance these different methods.
Keywords:
duration of response|estimands|restricted mean duration of response|restricted mean survival time|time to response|
Sponsors:
Biopharmaceutical Section
Tracks:
Statistical issues specific to therapeutic areas
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