Sex or Gender Reporting in Ophthalmology Clinical Trials Among US Food and Drug Administration Approvals, 1995 to 2022.

ABSTRACT:

Importance

As critical determinants of scientific rigor, reproducibility, and equity, sex and gender should be considered in clinical trial design and reporting.

Objective

To evaluate the accuracy of sex and gender reporting and extent of sex- and gender-based analysis in clinical trials associated with US Food and Drug Administration (FDA) drug approvals between January 1, 1995, and December 31, 2022.

Design, setting, and participants

In this cross-sectional study of participants enrolled in FDA ophthalmology trials, the following trial documents were reviewed by pairs of independent reviewers in decreasing order of priority: peer-reviewed publication, ClinicalTrials.gov report, and FDA medical and statistical reviews. Trial protocols and supplementary materials were

SUBMITTER: Xie JS 

PROVIDER: S-EPMC12285576 | biostudies-literature | 2024 Feb

REPOSITORIES: biostudies-literature