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Translating Molecules into Medicines pp 297–315Cite as

Design of Clinical Studies in Early Development

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 25))

Abstract

There is growing philosophy in the realm of drug discovery that rapid feedback from strategic and tactical early clinical studies is one of the most vital components to optimizing the cycle of successful drug design. The current early development paradigms however do not always support the rapid relay of this vital clincal information to early drug discovery teams. Several industrial, government and academic initiatives are underway to improve the efficiency of the discovery to clinical information feedback loop, thereby increasing the number of drug therapies ultimately commercialized. Success will lie in early, proactive clinical biomarker and diagnostics identification and/or co-development, an early and sustained focus on predictive model development, application of early, adaptive clinical design strategies, and the use of fully integrated information technology (IT) and knowledge management (KM) systems.

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Author information

Authors and Affiliations

  1. Pfizer Inc., Cambridge, MA, 02139, USA

    Margaret S. Landis

Authors
  1. Margaret S. Landis
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Correspondence to Margaret S. Landis .

Editor information

Editors and Affiliations

  1. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    Shobha N. Bhattachar

  2. Pharmaceutical Candidate Optimization, Bristol-Myers Squibb, Wallingford, Connecticut, USA

    John S. Morrison

  3. ADME, Drug Disposition, Eli Lilly and Company, Indianapolis, Indiana, USA

    Daniel R. Mudra

  4. Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, Indiana, USA

    David M. Bender

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© 2017 American Association of Pharmaceutical Scientists

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Landis, M.S. (2017). Design of Clinical Studies in Early Development. In: Bhattachar, S., Morrison, J., Mudra, D., Bender, D. (eds) Translating Molecules into Medicines. AAPS Advances in the Pharmaceutical Sciences Series, vol 25. Springer, Cham. https://doi.org/10.1007/978-3-319-50042-3_9

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