Clinical trials in Europe and the development of new psychotropics as viewed by European manufacturers.
A number of external and internal (industry-specific) difficulties and problems related to clinical trials and the development of new psychotropics in Europe, are reviewed. These can be classified into 3 interdependent categories of problems: 1. strategy-related; 2. implementation-related; 3. time-related. Apart from ethical and methodological issues, the external problems are: a) diversity of country-specific regulations and requirements for registration and drug approval; b) differences in culture, traditions, education and training background of investigators and patients; c) high competition for good trial centers; d) increasing pressure and negative attitude from public media with respect to clinical testing of drugs. In the strategic planning of the development of a new drug, resources and heavy/costly logistic commitments for each individual study have to be taken into consideration. For the manufacturers it is therefore imperative to fix the plans and the kind of the studies to be performed sometimes several years in advance. Conflict often arises with respect to the developmental changes, both in environmental conditions and in the state of the art. Implementation of the clinical, particularly multicenter/multinational trials poses problems of multilingual documentation, heavy logistics of drug supply, quality control and monitoring of the studies. Inherent to these European problems is a unproportional high time expenditure which has important consequences for scientific progress and economy. Possible solutions for these problems are discussed. The initial steps in this direction will be the establishment of European standards for clinical trials, and uniform requirements for drug registration and approval.
Pharmaceuticals Division, CIBA-GEIGY Ltd., Basle, Switzerland.
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Delini-Stula
D002986:Clinical Trials as Topic / Q000639:trends*; D004345:Drug Industry; D005060:Europe; D006801:Humans; D011619:Psychotropic Drugs
D011619:Psychotropic Drugs