Seeing the Trees From the Forest: Challenges in Subgroup Analysis-Based Guidelines in Oncology.

As clinical trials in oncology require substantial efforts, maximizing the insights gained from them by conducting subgroup analyses is often attempted. The goal of these analyses is to identify subgroups of patients who are likely to benefit, as well as the subgroups of patients who are unlikely to benefit from the studied intervention. International guidelines occasionally include or exclude novel medications and technologies for specific subpopulations based on such analyses of pivotal trials without requiring confirmatory trials. This Perspective discusses the importance of providing a complete dataset of clinical information when reporting subgroup analyses and explains why such transparency is key for better clinical interpretation of the results and the appropriate application to clinical care, by providing examples of transparent reporting of clinical studies and examples of incomplete reporting of clinical studies.

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Copyright © 2024 Rotem, Geiger, Hanovich, Moskovitz, Kurman, Reinhorn, Peretz, Yerushalmi and Stemmer.

Déclaration de conflit d'intérêts

OR reports being a speaker for AstraZeneca, Boehringer Ingelheim, BMS, MSD, Novartis, Pfizer, Roche, Takeda, and Teva, and being a consultant for Rhenium, NucleaiMD, and Edocate. MM reports reported receiving a research grant from AstraZeneca, being a speaker for AstraZeneca, Roche, MSD, BMS, Pfizer, Novartis, Abbvie, and Takeda, and being a consultant for MSD and Takeda. DR reports being a speaker for BMS. RY reports receiving research grant from Roche, being a speaker for Roche, Novartis, MSD, AstraZeneca, and Eli Lilly, and being a consultant for Roche, Pfizer, Novartis, Medison, AstraZeneca, Gilead, and Eli Lilly. SS reports receiving a research grant from Can-Fite, AstraZeneca, Bioline RX, BMS, Halozyme, Clovis Oncology, CTG Pharma, Exelexis, Geicam, Halozyme, Incyte, Lilly, Moderna, Teva pharmaceuticals, and Roche, and owning stocks and options in CTG Pharma, DocBoxMD, Tyrnovo, VYPE, Cytora, and CAN-FITE. Author KG was employed by Leumit Health Services. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.