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.
KeywordsPlacebo Toxicity Europe Marketing Assure
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- 1.Weimer, D.L., Safe-and available-drugs, in: Instead of Regulation: Alternatives to Federal Regulatory Agencies (R.W. Poole, ed.), Lexington Books, Lexington, 1982, p. 261.Google Scholar
- 2.Tucker, D., The World Health Market, Euromonitor Publications, Ltd., Guildford, 1984, p. 62.Google Scholar
- 3.Hershey, N., and Miller, R.D., Human Experimentation and the Law ,Aspen Systems Corporation, Germantown, 1976, pp. 6–7.Google Scholar
- 6.Barber, B., Informed Consent in Medical Therapy and Research ,Rutgers University Press, New Brunswick, 1980, p. 157.Google Scholar
- 7.Code of Federal Regulations, Title 21, Part 310.3.Google Scholar
- 9.Code of Federal Regulations, Title 21, Part 314.126.Google Scholar
- 11.Lyon, J., and Riley, W.A., Demographics of 400 volunteer subjects with peptic ulcer disease. Manuscript in preparation.Google Scholar
- 12.Weimer, D.L., Safe-and available-drugs, in: Instead of Regulation: Alternatives to Federal Regulatory Agencies (R.W. Poole, ed.), Lexington Books, Lexington, 1982, pp. 252–253.Google Scholar
- Bezold, C. (ed.), Pharmaceuticals in the Year 2000: The Changing Context for Drug R&D, Institute for Alternative Futures, Alexandria, 1983.Google Scholar
- Shapiro, S.H., and Louis, T.A. (eds.), Clinical Trials: Issues and Approaches ,Marcel Dekker, Inc., New York, 1983.Google Scholar
- Tygstrup, N., Lachin, J.M., and Juhl, E. (eds.), The Randomized Clinical Trial and Therapeutic Decisions ,Marcel Dekker, Inc., New York, 1982.Google Scholar