Authors will be prompted to provide details on how sex and gender were considered in study design.
— will be raising awareness of the updated recommendations in letters to authors and reviewers during peer review. The aim here is to improve understanding of the degree to which sex and gender reporting is already part of study design, data collection and analysis in the research these journals publish. The journals will also evaluate author and reviewer reception of the changes so that we can iterate on them as we learn through experience.
The new measures are needed because research is still mostly failing to account for sex and gender in study design, sometimes with catastrophic results. Between 1997 and 2001, ten prescription drugs were withdrawn from use in the United States; eight of these were reported to have worse side effects in women than in men . These differences had probably been missed, in part, because of insufficient or inappropriate analysis of data on sex differences during clinical trials.
By introducing these changes, we aim to promote transparency in study design and, ultimately, make findings more accurate. Over time, we hope to see integration of sex and gender analysis in study design by default.
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