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A Perspective on the Process of Designing and Conducting Clinical Trials

In: Principles and Practice of Clinical Trials

Author

Listed:
  • 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)

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.

Suggested Citation

  • Curtis L. Meinert & Steven Piantadosi, 2022. "A Perspective on the Process of Designing and Conducting Clinical Trials," Springer Books, in: Steven Piantadosi & Curtis L. Meinert (ed.), Principles and Practice of Clinical Trials, chapter 125, pages 2453-2473, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-52636-2_175
    DOI: 10.1007/978-3-319-52636-2_175
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