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Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.
BMJ. 2017 Feb 07; 356:j337.BMJ

Abstract

OBJECTIVES

To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.

DESIGN

Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.

SETTING

Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.

MAIN OUTCOME MEASURES

Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.

RESULTS

Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.

CONCLUSIONS

Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians' reporting behaviours of adverse drug reactions.

Authors+Show Affiliations

Transparency International Deutschland eV, Working Group on Health and Working Group on Freedom of Information, Alte Schönhauser Strasse 44, 10119 Berlin, Germany spelsberg@tuzac.de. Comprehensive Cancer Centre Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany.Institute of Public Health, Charité - Universitätsmedizin Berlin, Seestrasse 73, 13347 Berlin, Germany.University of Maryland School of Pharmacy, Pharmaceutical Health Services Research Department, Baltimore, MD, USA.Comprehensive Cancer Centre Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany.Comprehensive Cancer Centre Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany.Transparency International Deutschland eV, Working Group on Health and Working Group on Freedom of Information, Alte Schönhauser Strasse 44, 10119 Berlin, Germany.Transparency International Deutschland eV, Working Group on Health and Working Group on Freedom of Information, Alte Schönhauser Strasse 44, 10119 Berlin, Germany. Institute of Epidemiology and Social Medicine, University of Münster, Albert Schweitzer Campus, 48149 Münster, Germany.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

28174182

Citation

Spelsberg, Angela, et al. "Contribution of Industry Funded Post-marketing Studies to Drug Safety: Survey of Notifications Submitted to Regulatory Agencies." BMJ (Clinical Research Ed.), vol. 356, 2017, pp. j337.
Spelsberg A, Prugger C, Doshi P, et al. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ. 2017;356:j337.
Spelsberg, A., Prugger, C., Doshi, P., Ostrowski, K., Witte, T., Hüsgen, D., & Keil, U. (2017). Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. BMJ (Clinical Research Ed.), 356, j337. https://doi.org/10.1136/bmj.j337
Spelsberg A, et al. Contribution of Industry Funded Post-marketing Studies to Drug Safety: Survey of Notifications Submitted to Regulatory Agencies. BMJ. 2017 Feb 7;356:j337. PubMed PMID: 28174182.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies. AU - Spelsberg,Angela, AU - Prugger,Christof, AU - Doshi,Peter, AU - Ostrowski,Kerstin, AU - Witte,Thomas, AU - Hüsgen,Dieter, AU - Keil,Ulrich, AU - ,, Y1 - 2017/02/07/ PY - 2017/2/9/entrez PY - 2017/2/9/pubmed PY - 2017/3/31/medline SP - j337 EP - j337 JF - BMJ (Clinical research ed.) JO - BMJ VL - 356 N2 - OBJECTIVES: To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. DESIGN: Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. SETTING: Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. MAIN OUTCOME MEASURES: Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. RESULTS: Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. CONCLUSIONS: Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the sponsor. High remuneration and strict confidentiality clauses in these studies could influence the physicians' reporting behaviours of adverse drug reactions. SN - 1756-1833 UR - https://www.unboundmedicine.com/medline/citation/28174182/Contribution_of_industry_funded_post_marketing_studies_to_drug_safety:_survey_of_notifications_submitted_to_regulatory_agencies_ L2 - http://www.bmj.com/cgi/pmidlookup?view=long&pmid=28174182 DB - PRIME DP - Unbound Medicine ER -