A Perspective on the Process of Designing and Conducting Clinical Trials

Curtis L. Meinert () and Steven Piantadosi ()
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Curtis L. Meinert: Johns Hopkins University, Department of Epidemiology, School of Public Health
Steven Piantadosi: Brigham and Women’s Hospital, Harvard Medical School, Department of Surgery, Division of Surgical Oncology

Chapter 125 in Principles and Practice of Clinical Trials, 2022, pp 2453-2473 from Springer

Abstract: 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.

Keywords: Design issues; Organization; Governance (search for similar items in EconPapers)
Date: 2022
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DOI: 10.1007/978-3-319-52636-2_175

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