{"title":"The Role of Different Risk Groups and Treatment Assignment Probabilities in Subgroup Analysis of Randomized Trials","authors":"Vadim Lesan, Vlada Odaie, Cristian Munteanu","doi":"10.1002/hon.70132","DOIUrl":null,"url":null,"abstract":"<div>\n \n <p>Retrospective subgroup analyses can introduce significant bias in the estimation of hazard ratios (HRs), particularly when patient distributions across treatment arms are imbalanced. Such disparities can distort the validity of HR outcomes, especially in the presence of unequal risk group compositions and varying treatment assignment probabilities. These factors may artificially shift HR estimates across different risk populations, leading to misleading correlations between subgroup classifications and treatment effects. To quantify this phenomenon, we conducted Monte Carlo simulations across 1000 trials, demonstrating how hazard ratios vary systematically with changes in the underlying risk group population. These findings underscore the need for caution in interpreting HRs from subgroup analyses and highlight the importance of robust trial design to mitigate bias.</p>\n </div>","PeriodicalId":12882,"journal":{"name":"Hematological Oncology","volume":"43 5","pages":""},"PeriodicalIF":3.9000,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Hematological Oncology","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/hon.70132","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Retrospective subgroup analyses can introduce significant bias in the estimation of hazard ratios (HRs), particularly when patient distributions across treatment arms are imbalanced. Such disparities can distort the validity of HR outcomes, especially in the presence of unequal risk group compositions and varying treatment assignment probabilities. These factors may artificially shift HR estimates across different risk populations, leading to misleading correlations between subgroup classifications and treatment effects. To quantify this phenomenon, we conducted Monte Carlo simulations across 1000 trials, demonstrating how hazard ratios vary systematically with changes in the underlying risk group population. These findings underscore the need for caution in interpreting HRs from subgroup analyses and highlight the importance of robust trial design to mitigate bias.
期刊介绍：
Hematological Oncology considers for publication articles dealing with experimental and clinical aspects of neoplastic diseases of the hemopoietic and lymphoid systems and relevant related matters. Translational studies applying basic science to clinical issues are particularly welcomed. Manuscripts dealing with the following areas are encouraged:
-Clinical practice and management of hematological neoplasia, including: acute and chronic leukemias, malignant lymphomas, myeloproliferative disorders
-Diagnostic investigations, including imaging and laboratory assays
-Epidemiology, pathology and pathobiology of hematological neoplasia of hematological diseases
-Therapeutic issues including Phase 1, 2 or 3 trials as well as allogeneic and autologous stem cell transplantation studies
-Aspects of the cell biology, molecular biology, molecular genetics and cytogenetics of normal or diseased hematopoeisis and lymphopoiesis, including stem cells and cytokines and other regulatory systems.
Concise, topical review material is welcomed, especially if it makes new concepts and ideas accessible to a wider community. Proposals for review material may be discussed with the Editor-in-Chief. Collections of case material and case reports will be considered only if they have broader scientific or clinical relevance.
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