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Activity Number: 232
Type: Topic Contributed
Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract #314770 View Presentation
Title: Implementation of Sample Size Re-Estimation Designs in Confirmatory Clinical Trials
Author(s): Eva Miller*
Companies: InVentiv Health Clinical
Keywords: adaptive design, confirmatory studies
Abstract:

With adaptive trials (ADs) the study team needs to devote more time in planning and preparation than for traditional trials. Key considerations for logistical issues of ADs are well discussed by Krams and Quinlan (2006), and Gaydos (2009). Here we focus on specific AD implementation considerations for sample size re-estimation (SSR) and especially for unblinded sample size re-estimation (uSSR). Points to be covered include: - In maintaining trial integrity, it is critical for uSSR that the study design not reveal information regarding treatment effect. - Simulations are critical in looking at flows of enrollment and events before and during the study. - Timing of IA is critical to minimize uncertainty of the estimate. - "Overflow" needs to be minimized. It occurs during the period after the cut-point for IA in which the study continues enrollment while the data cleaning, report generation, and DMC review take place. - Clean data are critical to integrity of decisions based on IA. It is necessary to prioritize data cleaning efforts before IA to those most related to the study endpoints considered within IA. - Appropriate communication of the results from IA and DMC decisions.


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

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