Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol.

ABSTRACT:

Introduction

Women have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.

Objective

In an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.

Methodolo

SUBMITTER: Matthewson A 

PROVIDER: S-EPMC7888323 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature