Cookies on this website

We use cookies to ensure that we give you the best experience on our website. If you click 'Accept all cookies' we'll assume that you are happy to receive all cookies and you won't see this message again. If you click 'Reject all non-essential cookies' only necessary cookies providing core functionality such as security, network management, and accessibility will be enabled. Click 'Find out more' for information on how to change your cookie settings.

Although outcomes in women's health are not as spectacular as in conditions like cancer, the large number of women who present each year means that the overall impact of these conditions is enormous. Similarly, although suboptimal therapies may not individually be much worse than best practice, the overall effect on a nation's health, wealth and happiness is substantial. There is a therefore a real need to gather evidence as to which, if any, women, benefit from any particular therapy. Well-designed randomised controlled trials (RCTs) help provide reliable evidence on a treatment's effectiveness. In this article, we consider important aspects of designing a good clinical trial; and in particular their application to women's health issues. Designed as an overview of the subject, we consider how large trials need to be; the choice of endpoints; how they should be analysed; and also more practical considerations in running a successful trial. The considerations given here are of use not only to clinicians or researchers preparing to run their own trial, but also to anyone who reads reports of trials, and should help clinicians make informed judgements about evidence presented in published reports. © 2006 Elsevier B.V. All rights reserved.

Original publication

DOI

10.1016/j.rigapp.2006.02.002

Type

Journal article

Journal

Reviews in Gynaecological and Perinatal Practice

Publication Date

01/06/2006

Volume

6

Pages

33 - 39