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Journal of Biopharmaceutical Statistics Volume 24, 2014 - Issue 1: Subgroup Analysis in Clinical Trials
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Original Articles

A Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups When Correctly Classified

Sue-Jane Wang Office of Biostatistics, OTS/CDER, Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
&
H. M. James Hung Division of Biometrics I, OB/OTS/CDER, Food and Drug Administration, Silver Spring, Maryland, USA
Pages 19-41 | Received 09 Aug 2013, Accepted 28 Aug 2013, Published online: 06 Jan 2014

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Ilya Lipkovich, Alex Dmitrienko, Christoph Muysers & Bohdana Ratitch. (2018) Multiplicity issues in exploratory subgroup analysis. Journal of Biopharmaceutical Statistics 28:1, pages 63-81.
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Toshimitsu Hamasaki, Scott R. Evans & Koko Asakura. (2018) Design, data monitoring, and analysis of clinical trials with co-primary endpoints: A review. Journal of Biopharmaceutical Statistics 28:1, pages 28-51.
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Alex Dmitrienko, Christoph Muysers, Arno Fritsch & Ilya Lipkovich. (2016) General guidance on exploratory and confirmatory subgroup analysis in late-stage clinical trials. Journal of Biopharmaceutical Statistics 26:1, pages 71-98.
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Articles from other publishers (18)

Cynthia Huber, Tim Friede, Julia Stingl & Norbert Benda. (2021) Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection. Therapeutic Innovation & Regulatory Science 56:2, pages 244-254.
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Wanying Zhao, Wei Ma, Fan Wang & Feifang Hu. (2021) Incorporating covariates information in adaptive clinical trials for precision medicine. Pharmaceutical Statistics 21:1, pages 176-195.
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Matthew Plow, Tanya Packer, Virgil G. Mathiowetz, Kathy Preissner, Setareh Ghahari, Abdus Sattar, Francois Bethoux & Marcia Finlayson. (2020) REFRESH protocol: a non-inferiority randomised clinical trial comparing internet and teleconference to in-person ‘Managing Fatigue’ interventions on the impact of fatigue among persons with multiple sclerosis. BMJ Open 10:8, pages e035470.
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Alex Dmitrienko, Ilya Lipkovich, Aaron Dane & Christoph Muysers. 2020. Design and Analysis of Subgroups with Biopharmaceutical Applications. Design and Analysis of Subgroups with Biopharmaceutical Applications 33 91 .
Stefan Schandelmaier, Yaping Chang, Niveditha Devasenapathy, Tahira Devji, Joey S.W. Kwong, Luis E. Colunga Lozano, Yung Lee, Arnav Agarwal, Neera Bhatnagar, Hannah Ewald, Ying Zhang, Xin Sun, Lehana Thabane, Michael Walsh, Matthias Briel & Gordon H. Guyatt. (2019) A systematic survey identified 36 criteria for assessing effect modification claims in randomized trials or meta-analyses. Journal of Clinical Epidemiology 113, pages 159-167.
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Stan R W Wijn, Maroeska M Rovers, Ly H Le, Michail Belias, Jeroen Hoogland, Joanna IntHout, Thomas Debray & Johannes B Reitsma. (2019) Guidance from key organisations on exploring, confirming and interpreting subgroup effects of medical treatments: a scoping review. BMJ Open 9:8, pages e028751.
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Demissie Alemayehu, Yang Chen & Marianthi Markatou. (2017) A comparative study of subgroup identification methods for differential treatment effect: Performance metrics and recommendations. Statistical Methods in Medical Research 27:12, pages 3658-3678.
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Un Jung Lee, ShengLi Tzeng, Yu-Chuan Chen & James J Chen. (2018) Prognostic and predictive signatures for treatment decisions. Biomarkers in Medicine 12:8, pages 849-859.
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H. M. James Hung, Xiangmin Zhang & Sue-Jane Wang. (2017) Some Recent Advances on Statistical Approaches for Planning Multi-regional Clinical Trials. Statistics in Biosciences 10:2, pages 460-472.
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Yu-Chuan Chen, Un Jung Lee, Chen-An Tsai & James J. Chen. (2018) Development of predictive signatures for treatment selection in precision medicine with survival outcomes. Pharmaceutical Statistics 17:2, pages 105-116.
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Alex Dmitrienko, Brian MillenIlya Lipkovich. (2017) Multiplicity considerations in subgroup analysis. Statistics in Medicine 36:28, pages 4446-4454.
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Mohamed AloshMohammad F. HuqueFrank Bretz & Ralph B. D'AgostinoSr.Sr.. (2017) Tutorial on statistical considerations on subgroup analysis in confirmatory clinical trials. Statistics in Medicine 36:8, pages 1334-1360.
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Julien Tanniou, Ingeborg van der Tweel, Steven Teerenstra & Kit C. B. Roes. (2016) Subgroup analyses in confirmatory clinical trials: time to be specific about their purposes. BMC Medical Research Methodology 16:1.
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Ying DingHui-Min LinJason C. Hsu. (2016) Subgroup mixable inference on treatment efficacy in mixture populations, with an application to time-to-event outcomes. Statistics in Medicine 35:10, pages 1580-1594.
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Lindsay A. Renfro, Himel Mallick, Ming-Wen An, Daniel J. Sargent & Sumithra J. Mandrekar. (2016) Clinical trial designs incorporating predictive biomarkers. Cancer Treatment Reviews 43, pages 74-82.
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Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans & Toshimitsu OchiaiToshimitsu Hamasaki, Koko Asakura, Scott R. Evans & Toshimitsu Ochiai. 2016. Group-Sequential Clinical Trials with Multiple Co-Objectives. Group-Sequential Clinical Trials with Multiple Co-Objectives 97 102 .
Tzu-Pin Lu & James J. Chen. (2015) Identification of drug-induced toxicity biomarkers for treatment determination. Pharmaceutical Statistics 14:4, pages 284-293.
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Sue-Jane Wang & H.M. James Hung. (2013) Adaptive enrichment with subpopulation selection at interim: Methodologies, applications and design considerations. Contemporary Clinical Trials 36:2, pages 673-681.
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