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Regulatory Issues

In: Fundamentals of Clinical Trials

Author

Listed:
  • Lawrence M. Friedman

  • Curt D. Furberg

    (Wake Forest School of Medicine)

  • David L. DeMets

    (University of Wisconsin, Department of Biostatistics)

  • David M. Reboussin

    (Wake Forest School of Medicine, Department of Biostatistics)

  • Christopher B. Granger

    (Duke University, Department of Medicine)

Abstract

The purpose of a clinical trial is to assess reliably the benefits and harms of an intervention. In this book, we have focused on good clinical trial design, conduct, monitoring, and analysis principles. For many clinical trials, including those involving new drugs, devices, or biologics, or new indications for existing interventions, there are national and local regulations that must be followed in order to conduct clinical research, including the types of trials we have discussed. Furthermore, in order for an industry sponsor to market a medical product, regulatory agency approval is required in the U.S. and much of the rest of the world. The primary goal of this chapter is not to summarize all of the regulations relating to medical products; that is beyond the scope of this book. Rather, it is to focus on those laws, regulations and policies that bear on the design, conduct, and reporting of clinical trials. Even then, it will be highly selective, limited to those aspects that we think are most relevant and we will concentrate on U.S. laws, policies and regulations.

Suggested Citation

  • Lawrence M. Friedman & Curt D. Furberg & David L. DeMets & David M. Reboussin & Christopher B. Granger, 2015. "Regulatory Issues," Springer Books, in: Fundamentals of Clinical Trials, edition 0, chapter 0, pages 519-542, Springer.
    • Handle: RePEc:spr:sprchp:978-3-319-18539-2_22
    DOI: 10.1007/978-3-319-18539-2_22
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