Regulatory Issues

Lawrence M. Friedman (), Curt D. Furberg (), David L. DeMets (), David M. Reboussin () and Christopher B. Granger ()
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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

Chapter Chapter 22 in Fundamentals of Clinical Trials, 2015, pp 519-542 from Springer

Abstract: 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.

Date: 2015
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DOI: 10.1007/978-3-319-18539-2_22

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