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Introduction

  • Frank L. Iber
  • W. Anthony Riley
  • Patricia J. Murray

Abstract

Most of the scientific methods relating to human drug testing are undergoing orderly change. Animal testing of toxicity, evaluation of human therapeutic effects, statistical analysis, monitoring of improvement in disease, and design of human studies have changed in progressive steps that appeared slow and appropriate to those who lived through these changes but are dramatic when the changes are looked at in brief review. All of these changes result in better standards of laboratory and human testing such that what was commonplace and accepted even ten years ago is no longer up to the standard of today. Regulations, on the other hand, have usually changed abruptly in response to one or more seminal issues arising from abuse of the public. This introductory chapter will trace the development of the ethical and regulatory concepts that have influenced and controlled current research practices to provide a framework that the new investigator or research administrator may find useful in interpreting this work.

Keywords

Interstate Commerce United States Public Health Service Federal Regulatory Agency Current Research Practice Traditional Health Care System 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Further Reading

  1. Bezold, C. (ed.), Pharmaceuticals in the Year 2000: The Changing Context for Drug R&D, Institute for Alternative Futures, Alexandria, 1983.Google Scholar
  2. Shapiro, S.H., and Louis, T.A. (eds.), Clinical Trials: Issues and Approaches ,Marcel Dekker, Inc., New York, 1983.Google Scholar
  3. Tygstrup, N., Lachin, J.M., and Juhl, E. (eds.), The Randomized Clinical Trial and Therapeutic Decisions ,Marcel Dekker, Inc., New York, 1982.Google Scholar

Copyright information

© Plenum Publishing Corporation 1987

Authors and Affiliations

  • Frank L. Iber
    • 1
    • 2
  • W. Anthony Riley
    • 3
  • Patricia J. Murray
    • 4
  1. 1.Hines Veterans Administration Medical Center and Loyola University Stritch School of MedicineMayfieldUSA
  2. 2.University of Maryland School of MedicineBaltimoreUSA
  3. 3.Baltimore Medical System, Inc.BaltimoreUSA
  4. 4.BostonUSA

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