Lack of precision in the reporting of sex and gender in cancer clinical trials with a PRO endpoint: an exploratory literature review
Our review shows that most trials lack precision in reporting sex and/or gender, highlighting the educational need for distinguishing these concepts in the field of clinical trials with PRO endpoints. The synonymous use of the terms sex and gender does not do justice to their different conceptualizations and can hinder further research that is inclusive of sex and/or gender. Raising awareness and compliance with the SAGER guidelines in cancer clinical trials is needed to enhance the credibility of findings drawn regarding sex and/or gender differences.
Authors
- Monika Sztankay (ORCID: https://orcid.org/0000-0002-7938-1250)
- Nikola Komlenac (ORCID: https://orcid.org/0000-0002-2647-4461)
- Lisa M. Wintner (ORCID: https://orcid.org/0000-0003-0690-4708)
- Daniela Krepper (ORCID: https://orcid.org/0009-0009-0026-9548)
- Anna Margarete Maria Thurner (ORCID: https://orcid.org/0009-0000-3110-8389)
Institutions
- Innsbruck Medical University (AT)
- Universität Innsbruck (AT)
- University Hospital Innsbruck (AT)
Publication Details
- Journal
- BMC Medical Research Methodology
- Published
- 2025-11-11
- DOI
- https://doi.org/10.1186/s12874-025-02710-2
- Citations
- 1
- Primary Topic
- Sex and Gender in Healthcare
- Type
- article
- Field-Weighted Citation Impact
- 1.88