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Biomarker-Driven Adaptive Phase III Clinical Trials

In: Principles and Practice of Clinical Trials

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  • Richard Simon

    (R Simon Consulting)

Abstract

Developments in cancer genomics have dramatically changed oncology drug development. The discovery of important mutations in tumors has led to the development of drugs which target these alterations. This has rendered obsolete some older paradigms of clinical trial design and analysis. Newer paradigms emphasize use of narrow eligibility enrichment designs when the molecular target and drug are well characterized and adaptive designs when they are not. The pace of progress in tumor biology has accelerated and the size of treatment effects that can be expected when treating the right population has increased. Some of the conventional wisdom about effective clinical trial design that statisticians have taught to clinical investigators needs reevaluation. Success in oncology therapeutics development will be facilitated by the use of new, information-rich designs.

Suggested Citation

  • Richard Simon, 2022. "Biomarker-Driven Adaptive Phase III Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 120, pages 2367-2378, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_279
    DOI: 10.1007/978-3-319-52636-2_279
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