Characteristics of Post-hoc Subgroup Analyses of Oncology Clinical Trials: A Systematic Review
- Author(s)
- Alrawabdeh, J; Alzu'bi, M; Alzyoud, M; Odeh, N; Hamadneh, Y; Mian, H; Mohyuddin, GR; Kelkar, AH; Goodman, AM; Chakraborty, R; Russler-Germain, DA; Mehra, N; Baggio, D; Scheffer Cliff, ER; Al Hadidi, S;
- Details
- Publication Year 2023-11-25,Volume 7,Issue #6,Page pkad100
- Journal Title
- JNCI Cancer Spectrum
- Publication Type
- Review
- Abstract
- BACKGROUND: Subgroup analyses in clinical trials assess intervention effects on specific patient subgroups, ensuring generalizability. However, they are usually only able to generate hypotheses rather than definitive conclusions. This study examined the prevalence and characteristics of subgroup analysis. METHODS: We systematically reviewed published subgroup analyses from 2000-2022. We included articles presenting secondary, post-hoc, or subgroup analyses of interventional clinical trials in oncology, cancer survivorship, or cancer screening, published separately to the original clinical trial publication. We collected cancer type, year of publication, where and how subgroup analysis was reported, and funding. RESULTS: Out of 16,487-screened publications, 1,612 studies were included; primarily subgroup analyses of treatment trials for solid tumors (82%). Medical writers contributed to 31% of articles, and 58% of articles reported conflicts of interest. Subgroup analyses increased significantly over time, with 695 published between 2019-2022, compared to 384 from 2000-2014. Gastrointestinal tumors (25%) and lymphoid lineage tumors (39%) were the most frequently studied solid and hematological malignancies, respectively. Industry funding and reporting of conflicts of interest increased over time. Subgroup analyses often neglected to indicate their secondary nature in the title. Most authors were from high-income countries, most commonly North America (45%). CONCLUSIONS: This study demonstrates the rapidly growing use of subgroup analysis of oncology clinical trials, revealing that the majority are supported by pharmaceutical companies, and they frequently fail to indicate their secondary nature in the title. Given the known methodological limitations of subgroup analyses, caution is recommended among authors, readers, and reviewers when conducting and interpreting these studies.
- Publisher
- Oxford University Press
- Department(s)
- Pathology
- Publisher's Version
- https://doi.org/10.1093/jncics/pkad100
- Open Access at Publisher's Site
https://doi.org/10.1093/jncics/pkad100- Terms of Use/Rights Notice
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Creation Date: 2024-09-05 06:55:54
Last Modified: 2024-09-05 06:56:44