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Adaptive Trial Designs

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Clinical Trial Simulations

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 1))

Abstract

Adaptive designs (AD) have received a great deal of attention in recent years because of the potential they offer to improve the efficiency of clinical drug development. In an increasingly challenging environment, characterized by escalating costs and decreasing likelihood of regulatory approval, sponsors and regulators alike have a keen interest in strategies to modernize drug development – the use of AD is a key one among them.

This chapter presents an overview of AD and their use in clinical drug development. It starts with some background and definitions, followed by sections on AD in the Learn and Confirm phases of clinical development. In later sections, the importance of trial simulations in the context of AD is discussed, followed by thoughts on the future of AD.

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Author information

Authors and Affiliations

  1. Adaptive Designs, Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA

    José C. Pinheiro

Authors
  1. José C. Pinheiro
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  2. Frank Bretz
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  3. Chyi-Hung Hsu
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Corresponding author

Correspondence to José C. Pinheiro .

Editor information

Editors and Affiliations

  1. Department of Advanced Modeling & Simula, Janssen Research & Development, LLC, Route 202 S. 920, Raritan, 08869, New Jersey, USA

    Holly H. C. Kimko

  2. Dept. Biopharmaceutical Sciences, University of California, San Francisco, Parnassus Ave. 513, San Francisco, 94143-0446, California, USA

    Carl C. Peck

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Pinheiro, J.C., Bretz, F., Hsu, CH. (2011). Adaptive Trial Designs. In: Kimko, H., Peck, C. (eds) Clinical Trial Simulations. AAPS Advances in the Pharmaceutical Sciences Series, vol 1. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-7415-0_6

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