Differing attitudes of industry and academia towards controlled clinical trials
- 30 November 1986
- journal article
- research article
- Published by Wiley in European Journal of Clinical Investigation
- Vol. 16 (6) , 455-460
- https://doi.org/10.1111/j.1365-2362.1986.tb02161.x
Abstract
A consensus conference was held in 1984 on controversial issues concerning controlled clinical trials. Thirty-six individuals working in academic institutions, forty-six in industry and twelve in regulatory authorities participated. Academics accepted and industrial representatives rejected the following: (i) existing regulations cannot cope with the rate at which new treatments develop; (ii) drug companies may be reluctant to undertake surveillance programmes because sales will fall if adverse reactions are detected; (iii) novel remedies should not be promoted before extensive post-marketing surveillance; (iv) third parties should finance trials promising to reduce the costs of illness and (v) trialists should be separated from sponsors in data analysis and interpretation, the investigator owning the data unless stated otherwise. Industrial representatives supported and academics rejected the following: (i) government price control inhibits drug development and (ii) a multicentre trial can be justified simply by the wish to speed drug registration.Keywords
This publication has 7 references indexed in Scilit:
- Summary of a Workshop on the Role of Third-Party Payers in Clinical Trials of New AgentsNew England Journal of Medicine, 1983
- Comparison of German and American Law concerning clinical trialsControlled Clinical Trials, 1981
- From "Promising Report" to "Standard Procedure": Seven Stages in the Career of a Medical InnovationThe Milbank Memorial Fund Quarterly. Health and Society, 1981
- CONTROLLED CLINICAL TRIALS AND MEDICAL ETHICSThe Lancet, 1978
- Exact probabilities for tied linear rank testsJournal of Statistical Computation and Simulation, 1976
- A Locally Most Powerful Tied Rank Test in a Wilcoxon SituationThe Annals of Mathematical Statistics, 1971