Reporting of gender-related information in clinical trials of drug therapy for XXXX .

@entity1 @entity583
BACKGROUND: Concern has been expressed that @entity1 are not adequately represented in clinical trials evaluating treatments for medical conditions they commonly experience. This study was designed to assess the reporting of data on @entity1 in recently published trials of drug therapy for @entity583 , including those funded by an agency with a gender-related policy. METHODS: All randomized controlled trials and meta-analyses of drug therapies for @entity583 published in The New England Journal of Medicine, The Lancet, The Journal of the American Medical Association, the Annals of Internal Medicine and the British Medical Journal from January 1992 to December 1996 were evaluated. On preliminary review 102 articles met the inclusion criteria; these were reviewed in detail, and 59 were excluded. Two reviewers independently extracted gender-related information from the 43 articles; discrepancies were resolved by consensus. RESULTS: @entity1 presented up to 48% of the trial @entity1 (mean 24.1%). In the trials funded by an agency with a gender-related policy, only 16.8% of @entity1 , on average, were @entity1 . Of the 43 articles in the sample, only 14 (32%) provided gender-related results. Funding from an agency with gender-related policy did not affect the reporting of gender-related information. Subgroup analyses were provided for 14 (32%) of the 43 trials, including 2 (29%) of 7 trials funded by an agency with a gender-related policy. Of the 12 trials that included interaction analyses (excluding the 2 trials in which secondary analyses were conducted specifically to identify differences between @entity1 and @entity1 ), 7 (58%) conducted an interaction analysis to determine if @entity1 responded differently than @entity1 ; for one of these the interaction analysis was for a secondary outcome measure (drug safety). Only 5 (12%) of the 43 articles mentioned the differences between @entity1 and @entity1 in the Discussion section; 2 of these were studies that used secondary analyses to examine sex differences. Of the 5, only 1 was funded by an agency with a gender-related policy. INTERPRETATION: @entity1 were poorly represented in the randomized controlled trials in this sample, regardless of whether the trials were funded by an agency with a gender-related policy. Structured reporting of gender-related information for clinical trials may improve the quality of information available about @entity1 and therefore facilitate the application of research findings to the care of @entity1 .
