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Ethical Issues

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Fundamentals of Clinical Trials

Abstract

People have debated the ethics of clinical trials for as long as trials have been conducted. The arguments have changed over the years and perhaps become more sophisticated, but many of them involve issues such as the physician’s obligations to the individual patient versus societal good; clinical equipoise; study design considerations such as randomization and the choice of control group, including use of placebo; informed consent; conduct of trials in underdeveloped areas and world regions; conflicts of interest; participant confidentiality and sharing of data and specimens; lack of publication; and publication bias.

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Authors and Affiliations

  1. North Bethesda, MD, USA

    Lawrence M. Friedman

  2. Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA

    Curt D. Furberg

  3. Department Biostatistics and Medical Informatics, University of Wisconsin, Madison, WI, USA

    David L. DeMets

  4. Department of Biostatistics, Wake Forest School of Medicine, Winston-Salem, NC, USA

    David M. Reboussin

  5. Department of Medicine, Duke University, Durham, NC, USA

    Christopher B. Granger

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Friedman, L.M., Furberg, C.D., DeMets, D.L., Reboussin, D.M., Granger, C.B. (2015). Ethical Issues. In: Fundamentals of Clinical Trials. Springer, Cham. https://doi.org/10.1007/978-3-319-18539-2_2

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