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

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.