Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products

  • Anke Finnah Federal Office for Consumer Protection and Food Safety (BVL) Department Veterinary Drugs Mauerstraße 39-42 10117 Berlin
  • Sabine Klee Federal Office for Consumer Protection and Food Safety (BVL), Berlin, Germany
  • Inga Ruddat Department of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training in Veterinary Public Health, University of Veterinary Medicine, Hannover, Germany
  • Bettina Schneider Department of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training in Veterinary Public Health, University of Veterinary Medicine, Hannover, Germany
  • Lothar Kreienbrock Department of Biometry, Epidemiology and Information Processing, WHO Collaborating Centre for Research and Training in Veterinary Public Health, University of Veterinary Medicine, Hannover, Germany

Published:

2017-02-09

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DOI

https://doi.org/10.18849/ve.v2i1.49

Abstract

Objective: In the present study, the feasibility of a systematic record of clinical study data from marketing authorisation applications for veterinary medicinal products (VMP) and benefits of the selected approach were investigated.

Background: Drug registration dossiers for veterinary medicinal products contain extensive data from drug studies, which are not easily accessible to assessors.

Evidentiary value: Fast access to these data including specific search tools could facilitate a meaningful use of the data and allow assessors for comparison of test and studies from different dossiers.

Methods: First, pivotal test parameters and their mutual relationships were identified. Second, a data model was developed and implemented in a relational database management system, including a data entry form and various reports for database searches. Compilation of study data in the database was demonstrated using all available clinical studies involving VMPs containing the anthelmintic drug Praziquantel.
By means of descriptive data analysis possibilities of data evaluation including graphical presentation were shown. Suitability of the database to support the performance of meta-analyses was tentatively validated.

Results: The data model was designed to cover the specific requirements arising from study data. A total of 308 clinical studies related to 95 VMPs containing Praziquantel (single agent and combination drugs) was selected for prototype testing. The relevant data extracted from these studies were appropriately structured and shown to be basically suitable for descriptive data analyses as well as for meta-analyses.

Conclusion: The database-supported collection of study data would provide users with easy access to the continuously increasing pool of scientific information held by competent authorities. It enables specific data analyses. Database design allows expanding the data model to all types of studies and classes of drugs registered in veterinary medicine. The needs for detailed data recording and versatility of the data model must be carefully balanced.

Application: The database will be used by regulatory authorities.

References

ATCvet (2016) Collaboration Center for Drug Statistics Methodology. [WHO][online]. Available from: http://www.whocc.no/atcvet/. [Accessed 17 Aug 2016].

Bildner, C. (2008) Microsoft Access XP/2003 Basiswissen: Begleitheft für Access-Einsteiger. readersplanet GmbH, Passau.

Chen, PP-S. (1976) The entity-relationship model – toward a unified view of data. ACM Transactions on Database Systems, 1 (1), pp. 9-36. DOI http://dx.doi.org/10.1145/320434.320440

Clauß, G and Ebner, H. (1989) Statistik für Soziologen, Pädagogen, Psychologen und Mediziner. Frankfurt/M: Harri Deutsch Verlag, Thun.

gov (2015) U.S. National Institutes of Health [online]. Available from: https://www.clinicaltrials.gov/. [Accessed 06 Jan 2016].

Commission Regulation (EC) No. 1234/2008 (2008) concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. [online] Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:334:0007:0024:en:PDF [Accessed 28 Jan 2016]

Coordination Staff for Veterinary Clinical Studies (n.d.). [Universität Leipzig] [online]. Available from: http://parasitologie.vetmed.uni-leipzig.de/sites/default/files/Flyer%20koVet%202003.pdf. [Accessed 17 Aug 2016]

Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. [online]. Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:en:PDF. [Accessed 28 Jan 2016].

Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products. [online]. Available from: http://ec.europa.eu/health/files/eudralex/vol-5/dir_2001_82/dir_2001_82_en.pdf. [Accessed 28 Jan 2016].

Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP). [online] Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0028:0043:EN:PDF. [Accessed 27 Jan 2017]

Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances. [online] Available from: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:050:0044:0059:EN:PDF. [Accessed 27 Jan 2017].

European Directorate for the Quality of Medicines and Health Care. [EDQM Standard Terms] [online] Available from: https://standardterms.edqm.eu/ [Accessed 17 Aug 2016]

EU Clinical Trials Register (2016). [European Medicines Agency] [online]. Available from: https://www.clinicaltrialsregister.eu/. [Accessed 17 Aug 2016].

European Clinical Trials Database, EudraCT (2016) [European Medicines Agency] [online]. Available from: https://eudract.ema.europa.eu/index.html. [Accessed 17 Aug 2016].

Volume 6B, Notice to applicants: Veterinary medicinal products – Presentation and content of the dossier. [European Commission][online] Available from: http://ec.europa.eu/health/documents/eudralex/index_en.htm. [Accessed 28 Jan 2016].

German Clinical Trials Register (2014). [Center for Medical Biometry and Medical Informatics at the University Medical Center Freiburg]. Available from https://drks-neu.uniklinik-freiburg.de/drks_web/setLocale_EN.do. [Accessed 06 Jan 2016].

Karl und Veronica Carstens-Stiftung (2011) HomVetCR: Clinical Research on Veterinary Homeopathy. [online]. Available from: http://www.carstens-stiftung.de/clinresvet/suche.php. [Accessed 17 Aug 2016]

Health for Animals [IFAH Annual Report] [online]. Available from: http://healthforanimals.org/resources-and-events/resources/publications/76:ifah-annual-report-2013.html. [Accessed 17 Aug 2016].

Current Controlled [ISRCTN Registry] [online]. Available from: http://www.controlled-trials.com/, DOI http://dx.doi.org/10.18810/isrctn. [Accessed 17 Aug 2016].

Klug, U. (2008). Datenbankanwendungen entwerfen & programmieren. W3I-Verlag, Herdecke.

Medicinal Products Act (The Drug Law). Available from: https://www.gesetze-im-internet.de/englisch_amg/englisch_amg.pdf [Accessed 27 Jan 2017].

Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down the Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. [online] Available from: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF [Accessed 28 Jan 2016]

VetAllTrials (2015) [online] Available from: http://vetalltrials.org/ [Accessed 27 Jan 2017]

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. [VICH GL9: Good Clinical Practice] [online] Available from: http://www.vichsec.org/guidelines/pharmaceuticals/pharma-efficacy/good-clinical-practice.html. [Accessed 26 Jan 2017].

World Medical Association (2013). Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects. JAMA, 310 (20), p. 2191. DOI http://dx.doi.org/10.1001/jama.2013.281053.

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Keywords

feasibility study factual databases clinical trials drug evaluation secondary data usage
Vol. 2 No. 1 (2017): The first issue of 2017

Section: Articles

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