A unified framework for weighted parametric group sequential design (WPGSD)

03/18/2021
by   Keaven M Anderson, et al.
0

Group sequential design (GSD) is widely used in clinical trials in which correlated tests of multiple hypotheses are used. Multiple primary objectives resulting in tests with known correlations include evaluating 1) multiple experimental treatment arms, 2) multiple populations, 3) the combination of multiple arms and multiple populations, or 4) any asymptotically multivariate normal tests. In this paper, we focus on the first 3 of these and extend the framework of the weighted parametric multiple test procedure from fixed designs with a single analysis per objective to a GSD setting where different objectives may be assessed at the same or different times, each in a group sequential fashion. Pragmatic methods for design and analysis of weighted parametric group sequential design(WPGSD) under closed testing procedures are proposed to maintain the strong control of familywise Type I error rate (FWER) when correlations between tests are incorporated. This results in the ability to relax testing bounds compared to designs not fully adjusting for known correlations, increasing power or allowing decreased sample size. We illustrate the proposed methods using clinical trial examples and conduct a simulation study to evaluate the operating characteristics.

READ FULL TEXT
POST COMMENT

Comments

There are no comments yet.

Authors

page 4

03/13/2021

Closed testing procedures for treatment-versus-control comparisons and multiple correlated endpoint

Preferably in two- or three-arm randomized clinical trials, a few (2,3) ...
08/05/2021

Improving the Power of Economic Experiments Using Adaptive Designs

An important issue for many economic experiments is how the experimenter...
11/30/2020

Blinded sample size re-calculation in multiple composite population designs with normal data and baseline adjustments

The increasing interest in subpopulation analysis has led to the develop...
06/29/2018

Properties of the weighted log-rank test under delayed effects assumption in the design of confirmatory studies with delayed effects

Proportional hazards are a common assumption when designing confirmatory...
04/17/2020

Multiplicity for a Group Sequential Trial with Biomarker Subpopulations

Biomarker subpopulations have become increasingly important for drug dev...
08/27/2019

Optimizing Graphical Procedures for Multiplicity Control in a Confirmatory Clinical Trial via Deep Learning

In confirmatory clinical trials, it has been proposed [Bretz et al., 200...
02/16/2018

Design and Development of Effective Transmission Mechanisms on a Tendon Driven Hand Orthosis for Stroke Patients

Tendon-driven hand orthoses have advantages over exoskeletons with respe...
This week in AI

Get the week's most popular data science and artificial intelligence research sent straight to your inbox every Saturday.