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A Perspective on the Process of Designing and Conducting Clinical Trials

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Principles and Practice of Clinical Trials

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Abstract

Trials are not for the faint of heart. As noted by Donald Fredrickson (Director of the NIH: 1 July 1975 to 30 June 1981), “they lack glamor, they strain our resources and patience, and they protract the moment of truth to excruciating limits” (Fredrickson 1968). This chapter addresses issues in design and conduct of trials including who to study, choice of treatments to be tested, choice of outcome measures, and issues in monitoring and governance of the trial.

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Author information

Authors and Affiliations

  1. The Johns Hopkins Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, Baltimore, MD, USA

    Curtis L. Meinert

  2. Harvard Medical School, Brigham and Women’s Hospital, Boston, MA, USA

    Steven Piantadosi

Authors
  1. Curtis L. Meinert
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  2. Steven Piantadosi
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Corresponding author

Correspondence to Curtis L. Meinert .

Editor information

Editors and Affiliations

  1. Samuel Oschin Comprehensive Cancer Insti, WEST HOLLYWOOD, CA, USA

    Steven Piantadosi

  2. Bloomberg School of Public Health, Johns Hopkins Center for Clinical Trials Bloomberg School of Public Health, Baltimore, MD, USA

    Curtis L. Meinert

Section Editor information

  1. Rockville, Maryland, USA

    Lawrence Friedman

  2. Director, Office of Biostatistics Research, National Heart Lung and Blood Institute (NHLBI), Bethesda, MD, USA

    Nancy L Geller

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Meinert, C.L., Piantadosi, S. (2020). A Perspective on the Process of Designing and Conducting Clinical Trials. In: Piantadosi, S., Meinert, C. (eds) Principles and Practice of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-52677-5_175-1

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  • DOI: https://doi.org/10.1007/978-3-319-52677-5_175-1

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-52677-5

  • Online ISBN: 978-3-319-52677-5

  • eBook Packages: Springer Reference MathematicsReference Module Computer Science and Engineering

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