不同入组组合下试验的重新设计。

Redesign of trials under different enrollment mixes.

作者信息

Meinert C L

机构信息

Center for Clinical Trials, Johns Hopkins University, School of Hygiene and Public Health, Baltimore, Maryland 21205, USA.

出版信息

Stat Med. 1999 Feb 15;18(3):241-51; discussion 253-4. doi: 10.1002/(sici)1097-0258(19990215)18:3<241::aid-sim17>3.0.co;2-o.

DOI:10.1002/(sici)1097-0258(19990215)18:3<241::aid-sim17>3.0.co;2-o

PMID:10070670

Abstract

A few large multi-centre male-only heart trials done in the 1970s and 1980s have been seen as ill-conceived because they did not include females. The purpose here is to revisit two of those trials and to consider consequences in terms of cost and power had they been designed to include females.

摘要

20世纪70年代和80年代进行的一些大型多中心仅针对男性的心脏试验，被认为构思欠佳，因为这些试验没有纳入女性。本文的目的是重新审视其中两项试验，并考虑如果试验设计纳入女性，在成本和效能方面会产生怎样的结果。