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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
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmaceutical Biosciences. (Pharmacometrics)
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
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
Abstract [en]

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.
Keyword [en]
cost, GCP, Sweden, SDV
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-122057DOI: 10.1002/qaj.433OAI: oai:DiVA.org:uu-122057DiVA: diva2:308360
Available from: 2010-04-06 Created: 2010-04-06 Last updated: 2013-01-17Bibliographically approved

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