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非干预性研究的报酬——德国制药行业的一项调查结果

Remuneration for non-interventional studies--results of a survey in the pharmaceutical industry in Germany.

作者信息

Ruppert Thorsten, Hahn Michael, Hundt Ferdinand

机构信息

vfa - Research-Based Pharmaceutical Companies, Berlin, Germany.

出版信息

Ger Med Sci. 2012;10:Doc04. doi: 10.3205/000155. Epub 2012 Feb 7.

DOI:10.3205/000155
PMID:22355280
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3278977/
Abstract

In 2007 the Association of Research-Based Pharmaceutical Companies (vfa) published recommendations to improve the quality and transparency of non-interventional studies. These recommendations include quality assurance measures, in particular with respect to transparency as well as for the verification of the data collected in these studies. This publication presents the results of a survey on fees in non-interventional studies which was conducted within the member companies of the vfa in June 2011. These results demonstrate a consistent adherence to the statutory requirements and the implementation of the recommendations concerning the remuneration of the study centers. Depending on the indication, the number of routine doctor/patient contacts is different and associated with that number the documentation efforts vary. Accordingly, the fee varies based on the fee schedule for physicians (German: Gebührenordnung für Ärzte) by taking into account the actual efforts at the study center.

摘要

2007年,研究型制药公司协会(vfa)发布了旨在提高非干预性研究质量和透明度的建议。这些建议包括质量保证措施,特别是在透明度方面以及对这些研究中收集的数据进行核查。本出版物展示了2011年6月在vfa成员公司内部进行的一项关于非干预性研究费用的调查结果。这些结果表明,各公司始终遵守法定要求,并落实了有关研究中心报酬的建议。根据适应症不同,常规医生/患者接触的次数有所不同,与之相关的文件整理工作也有所差异。因此,费用会根据医生收费标准(德语:Gebührenordnung für Ärzte),同时考虑研究中心的实际工作量而有所不同。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8dc/3278977/b0fe2ff8dd28/GMS-10-04-t-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8dc/3278977/4d095a90f2fe/GMS-10-04-t-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8dc/3278977/b0fe2ff8dd28/GMS-10-04-t-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8dc/3278977/4d095a90f2fe/GMS-10-04-t-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8dc/3278977/b0fe2ff8dd28/GMS-10-04-t-002.jpg

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本文引用的文献

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Results of a quality control on non-interventional studies.非干预性研究的质量控制结果。
Ger Med Sci. 2011;9:Doc21. doi: 10.3205/000144. Epub 2011 Aug 15.
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Results of a survey on applied quality standards in non-interventional studies among the members of the German Association of Research-based Pharmaceutical Companies.德国创新型制药企业协会成员开展的非干预性研究应用质量标准调查结果。
Ger Med Sci. 2010 Oct 27;8:Doc29. doi: 10.3205/000118.
3
A survey of german physicians in private practice about contacts with pharmaceutical sales representatives.
一项针对私人执业德国医生与药品销售代表接触情况的调查。
Dtsch Arztebl Int. 2010 Jun;107(22):392-8. doi: 10.3238/arztebl.2010.0392. Epub 2010 Jun 4.
4
Small gifts sustain sales.小礼物能促进销售。
Dtsch Arztebl Int. 2010 Jun;107(22):390-1. doi: 10.3238/arztebl.2010.0390. Epub 2010 Jun 4.
5
Quality assurance in non-interventional studies.非干预性研究中的质量保证。
Ger Med Sci. 2009 Nov 9;7:Doc29. doi: 10.3205/000088.