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[利益冲突与临床药物试验——制药行业的影响及其对医学科学诚信的侵害]

[Conflicts of interest and clinical drug trials -- impact of the pharmaceutical industry and the impingement on the integrity of medical science].

作者信息

Ludwig Wolf-Dieter, Hildebrandt Martin, Schott Gisela

机构信息

Arzneimittelkommission der deutschen Arzteschaft, Herbert-Lewin-Platz 1, 10623 Berlin.

出版信息

Z Evid Fortbild Qual Gesundhwes. 2009;103(3):149-54. doi: 10.1016/j.zefq.2009.02.018.

Abstract

Numerous studies have addressed the subject of the extent and consequences of financial ties between pharmaceutical companies, academic institutions and clinical researchers. Based on these reports, guidelines for the management of conflicts of interest have been developed which give priority to the patients' welfare on all levels of interaction between doctors and industrial sponsors. The declaration of potential conflicts of interest and strict adherence to guidelines are mandatory to retain the physicians' credibility, reputation, and professional autonomy. Enhanced transparency in the conduct and analysis of clinical trials should be regarded as a valuable tool to uncover and avoid undue influence on clinical trials and derived prescription recommendations.

摘要

众多研究探讨了制药公司、学术机构和临床研究人员之间财务关系的程度及后果这一主题。基于这些报告,已制定了利益冲突管理指南,该指南在医生与行业赞助商互动的各个层面都将患者福利置于首位。申报潜在利益冲突并严格遵守指南对于维护医生的信誉、声誉和职业自主性而言是必不可少的。临床试验实施与分析过程中增强透明度应被视为一种有价值的工具,用以发现并避免对临床试验及由此得出的处方建议产生不当影响。

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