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Abstract
This report reviews the 100 most recently approved drugs in order to quantify the
frequency with which post-marketing studies of drug efficacy can be performed experimentally
and non-experimentally. These drugs represent 131 potential drug uses. Of them, the
absolute efficacy of 89 (68 percent) could be evaluated from clinical observations.
Of the remaining 42, six (14 percent) could be studied experimentally or non-experimentally,
six (14 percent) only experimentally, one (2 percent) only non-experimentally, and
29 (69 percent) by neither technique. Answers to all questions of relative efficacy
required formal research. Of these, 94 (72 percent) could be studied using either
experimental or non-experimental techniques. The remaining 37 (28 percent) could be
studied experimentally only. Thus, clinical observations and non-experimental research
can contribute a large proportion of the information about drug efficacy still needed
after marketing.
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References
- The evaluation of new drugs. current Food and Drug Administration regulations and statistical aspects of clinical trials.Arch Intern Med. 1967; 119: 547-556
- Drug monitoring.Academic Press, New York1977
- The discovery of drug induced illness.N Engl J Med. 1977; 296: 481-485
- Postmarketing follow-up.JAMA. 1979; 242: 2310-2314
- Drug evaluation after marketing.Ann Intern Med. 1979; 90: 257-261
- Can postmarketing surveillance help to effect optimal drug therapy?.JAMA. 1979; 242: 2420-2423
- Post-marketing surveillance of new drugs I: review of objectives and methodology.J Clin Pharmacol. 1979; 19: 85-94
Strom BL, Melmon KL, Miettinen OS. Post-marketing studies of drug efficacy: why? Submitted for publication.
- Efficacy of intervention practice: will epidemiology provide the answers?.in: Melmon KL Drug therapeutics—concepts for physician. 2nd ed. Elsevier-North Holland, New York1981: 201-208
- The need for randomization in the study of intended effects.Statistics in Medicine. 1983; 2: 267-271
- Postmarketing studies of drug efficacy: when must they be randomized?.Clin Pharmacol Ther. 1983; 34: 1-7
- Post-menopausal oestrogens protect against fractures of hip and distal radius.Lancet. 1979; II: 705-709
- The risk of hip fracture in post-menopausal females with and without estrogen drug exposure.Am J Public Health. 1981; 71: 138-144
- Decreased risk of fractures of the hip and lower forearm with postmenopausal use of estrogen.N Engl J Med. 1980; 303: 1195-1198
- Improved observational method for studying therapeutic efficacy. Suggestive evidence that lidocaine prophylaxis prevents death in acute myocardial infarction.JAMA. 1981; 246: 2455-2459
- The application of therapeutic trial principles to improve the design of epidemiologic research. A case-control study suggesting that anticoagulants reduce mortality in patients with myocardial infarction.J Chronic Dis. 1981; 34: 575-583
Article info
Publication history
Accepted:
April 4,
1984
Footnotes
☆This work was supported by a grant from the Joint Commission on Prescription Drug Use, by National Institutes of Health Training Grant GM-07546, and by grants from the Charles A. Dana Foundation, the Rockefeller Foundation, and the Andrew W. Mellon Foundation.
Identification
Copyright
© 1984 Published by Elsevier Inc.
