Quality assurance within the scope of Good Clinical Practice (GCP)—what is the cost of GCP‐related activities? A survey within the Swedish Association of the Pharmaceutical Industry (LIF)'s members

Abstract

Abstract The bureaucracy that the Good Clinical Practice (GCP) system generates, due to industry over‐interpretation of documentation requirements, clinical monitoring, data verifications etc. is substantial. The aim of this study was to estimate the percentage cost of all such GCP‐related activities within phase III clinical trials performed in Sweden in 2005. Method : An electronic questionnaire on ICH GCP‐activities and their related costs was sent to 47 of the 60 member companies of the Swedish Association of the Pharmaceutical Industry (LIF). Results : The number of respondents was 29, giving a response rate of 62% and covering 97% ( n =250) of phase III trials performed in Sweden in 2005. Approximately 50% of the total budget for a phase III study was reported to be GCP‐related. 50% of the GCP‐related cost was related to Source Data Verification (SDV). A vast majority (71%) of respondents did not support the notion that these GCP‐related activities increase the scientific reliability of clinical trials. Copyright © 2009 John Wiley & Sons, Ltd.