Epidemiological considerations in the design of controlled clinical trials. Part II: Methodology
Unlike the laboratory investigator who is able to manipulate experimental conditions precisely, the clinical epidemiologist studies disease and its treatment or prevention in humans who cannot be subjected to such rigid control available in the basic science laboratory. Special research strategies have therefore been designed to evaluate the efficacy of new treatments for diseases in humans. This report presents a brief review of the available methods, the rationale for their use, and the problems involved in their implementation, with particular reference to neurological diseases.
KeywordsControl Clinical Trial Therapeutic Trial Motor Neurone Disease Transient Ischaemic Attack Aluminium Level
Unable to display preview. Download preview PDF.
- Armitage, P. (1971). Statistical Methods in Medical Research. Blackwell Scientific Publications, Oxford.Google Scholar
- Cornfield, J. (1959). Principles of research. Am. J. Ment. Defic, 64, 240–52.Google Scholar
- Good, C. S. (1976). The Principles and Practice of Clinical Trials. Churchill Livingstone, London.Google Scholar
- Lilienfeld, A. M. and Lilienfeld, D. E. (1980). Foundations of Epidemiology. Oxford University Press, New York, pp. 256–74.Google Scholar
- Macrae, K. D. (1976). Statistical aspects of trial design. In Good, C. S. (ed.), The Principles and Practice of Clinical Trials. Churchill Livingstone, London, pp. 87–92.Google Scholar
- Schoenberg, B. S. (1978). Epidemiology of the inherited ataxias. In Kark, P., Rosenberg, R. and Schut, L. (eds), The Inherited Ataxias: Biochemical, Viral and Pathological Studies. Raven Press, New York, pp. 15–32.Google Scholar
- Schoenberg, B. S. (1979). The epidemiologic approach to Huntington’s disease. In Chase, T., Wexler, N. and Barbeau, A. (eds), Huntington’s Disease. Raven Press, New York, pp. 1–11.Google Scholar