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Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies
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 studi...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group Ltd.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477378/ https://www.ncbi.nlm.nih.gov/pubmed/28174182 http://dx.doi.org/10.1136/bmj.j337 |
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author | Spelsberg, Angela Prugger, Christof Doshi, Peter Ostrowski, Kerstin Witte, Thomas Hüsgen, Dieter Keil, Ulrich |
author_facet | Spelsberg, Angela Prugger, Christof Doshi, Peter Ostrowski, Kerstin Witte, Thomas Hüsgen, Dieter Keil, Ulrich |
author_sort | Spelsberg, Angela |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5477378 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group Ltd. |
record_format | MEDLINE/PubMed |
spelling | pubmed-54773782017-06-29 Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies Spelsberg, Angela Prugger, Christof Doshi, Peter Ostrowski, Kerstin Witte, Thomas Hüsgen, Dieter Keil, Ulrich BMJ Research 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. BMJ Publishing Group Ltd. 2017-02-07 /pmc/articles/PMC5477378/ /pubmed/28174182 http://dx.doi.org/10.1136/bmj.j337 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Research Spelsberg, Angela Prugger, Christof Doshi, Peter Ostrowski, Kerstin Witte, Thomas Hüsgen, Dieter Keil, Ulrich Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title | Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title_full | Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title_fullStr | Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title_full_unstemmed | Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title_short | Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
title_sort | contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477378/ https://www.ncbi.nlm.nih.gov/pubmed/28174182 http://dx.doi.org/10.1136/bmj.j337 |
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