Biomarker-Based Designs of Phase III Clinical Trials for Personalized Medicine

Shigeyuki Matsui (), Takahiro Nonaka () and Yuki Choai ()
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Shigeyuki Matsui: Nagoya University, Department of Biostatistics, Graduate School of Medicine
Takahiro Nonaka: Pharmaceuticals and Medical Devices Agency
Yuki Choai: The Graduate University for Advanced Studies, Department of Statistical Science, School of Multidisciplinary Sciences

Chapter Chapter 14 in Developments in Statistical Evaluation of Clinical Trials, 2014, pp 247-263 from Springer

Abstract: Abstract Advances in biotechnology and genomics have accelerated development of molecularly targeted treatments and prognostic and predictive biomarkers, particularly, in oncology. This chapter provides an overview of various biomarker-based designs for phase III randomized clinical trials to evaluate clinical utility of a biomarker or biomarker-based treatment, including biomarker-strategy, enrichment, and randomize-all designs. We also provide a simulation comparison of the randomize-all designs in terms of their ability to assert treatment efficacy for the correct patient population. Complex adaptive designs with development and validation of predictive biomarkers are also discussed.

Keywords: Treatment Efficacy; Estimate Treatment Effect; Entire Patient Population; Archive Specimen; Qualitative Interaction (search for similar items in EconPapers)
Date: 2014
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Persistent link: https://EconPapers.repec.org/RePEc:spr:sprchp:978-3-642-55345-5_14

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DOI: 10.1007/978-3-642-55345-5_14

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