适应性设计对于确证性试验的实用性如何？

How practical are adaptive designs likely to be for confirmatory trials?

作者信息

Gould A Lawrence

机构信息

Merck Research Laboratories, West Point, PA 19486, USA.

出版信息

Biom J. 2006 Aug;48(4):644-9; discussion 660-2. doi: 10.1002/bimj.200610242.

DOI:10.1002/bimj.200610242

PMID:16972716

Abstract

This is a discussion of the following papers appearing in this special issue on adaptive designs: 'Confirmatory Seamless Phase II/III Clinical trials with Hypotheses Selection at Interim: General Concepts' by Frank Bretz, Heinz Schmidli, Franz König, Amy Racine and Willi Maurer; and 'Confirmatory Seamless Phase II/III Clinical Trials with Hypotheses Selection at Interim: Applications and Practical Considerations' by Heinz Schmidli, Frank Bretz, Amy Racine and Willi Maurer.

摘要

本文讨论了发表在本期适应性设计特刊上的以下两篇论文

Frank Bretz、Heinz Schmidli、Franz König、Amy Racine和Willi Maurer所著的《中期进行假设选择的验证性无缝II/III期临床试验：一般概念》；以及Heinz Schmidli、Frank Bretz、Amy Racine和Willi Maurer所著的《中期进行假设选择的验证性无缝II/III期临床试验：应用与实际考虑》。