Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial

Détails

ID Serval
serval:BIB_71C7368FC6E5
Type
Actes de conférence (partie): contribution originale à la littérature scientifique, publiée à l'occasion de conférences scientifiques, dans un ouvrage de compte-rendu (proceedings), ou dans l'édition spéciale d'un journal reconnu (conference proceedings).
Sous-type
Abstract (résumé de présentation): article court qui reprend les éléments essentiels présentés à l'occasion d'une conférence scientifique dans un poster ou lors d'une intervention orale.
Collection
Publications
Titre
Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial
Titre de la conférence
2011 Joint Annual Meeting of the German, Swiss, and Austrian Societies for Clinical Pharmacology and Toxicology
Auteur(s)
Gotta V., Vallotton L., Widmer N., Buclin T.
Adresse
Zürich, Switzerland, October 20-22, 2011
ISSN-L
0306-5251
Statut éditorial
Publié
Date de publication
2011
Peer-reviewed
Oui
Volume
72
Série
British Journal of Clinical Pharmacology
Pages
7
Langue
anglais
Résumé
Introduction: We launched an investigator-initiated study (ISRCTN31181395) to evaluate the potential benefit of pharmacokinetic-guided dosage individualization of imatinib for leukaemiapatients followed in public and private sectors. Following approval by the research ethics committee (REC) of the coordinating centre, recruitment throughout Switzerland necessitatedto submit the protocol to 11 cantonal RECs.Materials and Methods: We analysed requirements and evaluation procedures of the 12 RECs with associated costs.Results: 1-18 copies of the dossier, in total 4300 printed pages, were required (printing/posting costs: ~300 CHF) to meet initial requirements. Meeting frequencies of RECs ranged between 2 weeks and 2 months, time from submission to fi rst feedback took 2-75 days. Study approval was obtained from a chairman, a subor the full committee, the evaluation work being invoiced by0-1000 CHF (median: 750 CHF, total: 9200 CHF). While 5 RECs gave immediate approval, the other 6 rose in total 38 queries before study release, mainly related to wording in the patient information, leading to 7 different fi nal versions approved. Submission tasks employed an investigator half-time over about 6 months.Conclusion: While the necessity of clinical research evaluation by independent RECs is undisputed, there is a need of further harmonization and cooperation in evaluation procedures. Current administrative burden is indeed complex, time-consuming and costly. A harmonized electronic application form, preferably compatible with other regulatory bodies and European countries, could increase transparency, improve communication, and encourage academic multi-centre clinical research in Switzerland.
Web of science
Création de la notice
28/10/2011 16:21
Dernière modification de la notice
20/08/2019 14:30
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