ArticleJournal of the National Cancer Institute2022
An Evaluation of Sex- and Gender-Based Analyses in Oncology Clinical Trials.
Article in Journal of the National Cancer Institute, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Sex-based prognosis in industry-sponsored advanced solid tumor trials: an individual participant data meta-analysis of survival and adverse events.Journal of the National Cancer Institute · 2026Pooled it
- Do female and male patients derive similar benefits from approved systemic oncology therapies? A systematic review and meta-analysis.Journal of cancer research and clinical oncology · 2023Pooled it
- Adjuvant dendritic cell-based immunotherapy in melanoma: insights into immune cell dynamics and clinical evidence from a phase II trial.Journal of translational medicine · 2025Trial
- Claims of sex-dependent effects in the behavioral and brain sciences are infrequently supported by valid statistical comparisons.Proceedings of the National Academy of Sciences of the United States of America · 2026Article
- Article
- Lack of precision in the reporting of sex and gender in cancer clinical trials with a PRO endpoint: an exploratory literature review.BMC medical research methodology · 2025Review
- Five Data-Informed Principles for Advancing Inclusive Research in Clinical Trials: A Pharma Perspective.Advances in therapy · 2025Article
- Diversity and inclusivity in oncology: A narrative review and orientation for institutional measures in Germany.Translational oncology · 2025Review
- Gender Medicine in Computed Tomography Radiomics Analysis to Predict Disease Progression in Liver Respectable Colorectal Cancer Patients.Cancer medicine · 2025Article
- When "One Size Fits All" Fits None: A Commentary on the Impacts of the"Draft Canadian Breast Cancer Screening Guidelines" on Racialized Populations in Canada.Current oncology (Toronto, Ont.) · 2025Review
- Observational
- Doing Justice: Ethical Considerations Identifying and Researching Transgender and Gender Diverse People in Insurance Claims Data.Journal of medical systems · 2024Article
- Association of VEGFA polymorphisms with the risk of oesophageal cancer in Punjab, India: A case-control study.The Indian journal of medical research · 2024Article
- Outcome differences by sex in oncology clinical trials.Nature communications · 2024Article
- Sex or Gender Reporting in Ophthalmology Clinical Trials Among US Food and Drug Administration Approvals, 1995 to 2022.JAMA ophthalmology · 2024Article
- Genetic differences between smokers and never-smokers with lung cancer.Frontiers in immunology · 2023Review
- Sex differences in patients with gastrointestinal stromal tumours: do they exist and does it affect survival?ESMO open · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe objective of this study was to evaluate whether sex- and gender-based analyses and proper sex and gender terminology were used in oncology trials leading to regulatory drug approval.
methodsThe Food and Drug Administration (FDA) Hematology/Oncology Approvals and Safety Notifications page was used to identify all anticancer therapies that received FDA approval between 2012 and 2019. The trials used to support FDA drug approval were collected along with all available supplemental tables and study protocols. Documents were reviewed to determine if there was a plan to analyze results according to sex and gender and to determine if consistent sex and gender terminology were used.
resultsWe identified 128 randomized, controlled trials corresponding to a cancer medicine, which received FDA approval. No study specified how sex and gender were collected or analyzed. No study reported any information on the gender of participants. Sex and gender terminology were used inconsistently at least once in 76% (97 of 128) of studies. Among the 102 trials for nonsex-specific cancer sites, 89% (91 of 102) presented disaggregated survival outcome data by sex. No study presented disaggregated toxicity data by sex or gender.
conclusionThe majority of pivotal clinical trials in oncology fail to account for the important distinction between sex and gender and conflate sex and gender terminology. More rigor in designing clinical trials to include sex- and gender-based analyses and more care in using sex and gender terms in the cancer literature are needed. These efforts are essential to improve the reproducibility, generalizability, and inclusiveness of cancer research.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.