Lack of precision in the reporting of sex and gender in cancer clinical trials with a PRO endpoint: an exploratory literature review.

ABSTRACT:

Background

Sex and gender are acknowledged as pivotal variables in clinical research. However, the differences between the concepts are frequently neglected in medical research, resulting in limited generalizability of research findings and potential bias. This review portrays current reporting of sex and/or gender in cancer clinical trials with a patient-reported outcome (PRO) endpoint.

Methods

PubMed was searched to identify randomized controlled trials in patients with bladder, colorectal, and lung cancer, published between 2019 and February 2022. A double-review procedure was applied using the software DistillerSR. The data extraction form included information on the terms used to describe sex and/or gender. The Sex and Gender Equity in Research (SAGER) guidelines checkl

SUBMITTER: Krepper D 

PROVIDER: S-EPMC12606981 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature