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Practical issues in conducting multinational, multicenter trials managed by Contract Research Organisations

Published online by Cambridge University Press:  16 April 2020

M Placchi
M Placchi*
Affiliation:
UCB SA Pharma Sector, Research & Development, Chemin du Foriest, B-1420Braine-l’Alleud, Belgium
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Extract

Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.

The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.

Type
Research Article
Information
European Psychiatry , Volume 9 , Issue 3: European Committee for Standardisation of Clinical Trials with Psychotropics, ECST Strasbourg Forum III. 10-11 June 1993, Strasbourg, France , 1994 , pp. 151 - 153
Copyright
Copyright © Elsevier, Paris 1994

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References

Chmura Kraemer, HTelch, CFSelection and utilization of outcome measures in psychiatric clinical trials. Report on the 1988 Mac Arthur Foundation Network I Methodology Institute. Neuropsychopharmacology 1992:7:85–94Google Scholar
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