中期进行假设选择的验证性无缝II/III期临床试验：机遇与局限

Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations.

作者信息

Jenniso Christopher, Turnbull Bruce W

机构信息

Department of Mathematical Sciences, University of Bath, Bath BA2 7AY, UK.

出版信息

Biom J. 2006 Aug;48(4):650-5; discussion 660-2. doi: 10.1002/bimj.200610248.

DOI:10.1002/bimj.200610248

PMID:16972717

Abstract

This is a discussion of the following two papers 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

本文讨论本期关于适应性设计的特刊中的以下两篇论文

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：应用与实际考量》。