The costs of pharmacovigilance in clinical research: A survey from Germany

Article type: Research Article

Authors: Kehrel, Uwe

Affiliations: Institute of Business Administration at the Department of Chemistry and Pharmacy, Westfälische Wilhelms-Universität Münster, Leonardo-Campus 1, 48149 Münster, Germany, Tel.: +49 251 83 31815; Fax: +49 251 83 31818, E-mail: u.kehrel@uni-muenster.de

Abstract: This paper analyses the cost structure of pharmacovigilance in investigator-initiated clinical trials. A total of 24 cost estimates, which were provided by five different German Coordinating Centers for Clinical Trials, were included in the study. The highest costs were caused by the processes of Safety Management. At least 30% of the total pharmacovigilance costs were connected with the planning phase and 70% were connected with the implementation phase of a clinical trial. The analysis shows the importance of aspects of costing and funding at an early stage in the planning process.

Keywords: Clinical trials, investigator-initiated, pharmacovigilance, safety management, cost analysis

DOI: 10.3233/JRS-2010-0498

Journal: International Journal of Risk & Safety in Medicine, vol. 22, no. 2, pp. 67-70, 2010