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

Details

Serval ID
serval:BIB_71C7368FC6E5
Type
Inproceedings: an article in a conference proceedings.
Publication sub-type
Abstract (Abstract): shot summary in a article that contain essentials elements presented during a scientific conference, lecture or from a poster.
Collection
Publications
Institution
Title
Need of reduced and harmonized bureaucracy in multi-centre clinical research - a case-report from a Swiss trial
Title of the conference
2011 Joint Annual Meeting of the German, Swiss, and Austrian Societies for Clinical Pharmacology and Toxicology
Author(s)
Gotta V., Vallotton L., Widmer N., Buclin T.
Address
Zürich, Switzerland, October 20-22, 2011
ISSN-L
0306-5251
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
72
Series
British Journal of Clinical Pharmacology
Pages
7
Language
english
Abstract
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.
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Create date
28/10/2011 17:21
Last modification date
20/10/2020 11:12
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