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
2009 (English)In: Quality Assurance Journal, ISSN 1087-8378, E-ISSN 1099-1786, Vol. 12, no 1, 3-7 p.Article in journal (Refereed) Published
The bureaucracy that the Good Clinical Practice (GCP) system generates, due to industryover-interpretation of documentation requirements, clinical monitoring, dataverifications etc. is substantial. The aim of this study was to estimate the percentagecost of all such GCP-related activities within phase III clinical trials performed inSweden in 2005.Method: An electronic questionnaire on ICH GCP-activities and their related costs wassent to 47 of the 60 member companies of the Swedish Association of the PharmaceuticalIndustry (LIF).Results: The number of respondents was 29, giving a response rate of 62% andcovering 97% (n5250) of phase III trials performed in Sweden in 2005. Approximately50% 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 vastmajority (71%) of respondents did not support the notion that these GCP-relatedactivities increase the scientific reliability of clinical trials.
Place, publisher, year, edition, pages
2009. Vol. 12, no 1, 3-7 p.
cost, GCP, Sweden, SDV
IdentifiersURN: urn:nbn:se:uu:diva-122057DOI: 10.1002/qaj.433OAI: oai:DiVA.org:uu-122057DiVA: diva2:308360