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[德国的临床药物试验——从行业视角对现状的评估]

[Clinical drug trials in Germany--an assessment of current status from the viewpoint of industry].

作者信息

Baumbauer E

机构信息

Verband Forschender Arzneimittelhersteller e.V. (VFA), Bonn.

出版信息

Langenbecks Arch Chir Suppl Kongressbd. 1996;113:646-50.

PMID:9101960
Abstract

Drug development today is a highly professional and costly affair, whereby quality and speed are decisive competitive factors in a global setting. Germany is in the process of losing its attractiveness for clinical drug research as evidenced by a significant decrease in funding of clinical drug research which at the moment amounts to about 1.5 billion DM/year. This decrease is due to an adverse environment created by a certain anxiety in public opinion regarding technological advances, an overburden of regulations, lack of an infrastructure in hospitals to work according to GCP and a regulatory agency which has to compete with momentarily more effective agencies in Europe (UK, France). A joint effort between industry and the medical profession is called for to change this situation for the better.

摘要

如今,药物研发是一项专业性极强且成本高昂的工作,在全球范围内,质量和速度是决定性的竞争因素。德国正逐渐失去其对临床药物研究的吸引力,临床药物研究资金大幅减少便是明证,目前该资金每年约为15亿德国马克。这种减少是由于公众舆论对技术进步存在一定焦虑、监管负担过重、医院缺乏按照药品临床试验管理规范开展工作的基础设施以及监管机构不得不与欧洲(英国、法国)目前更高效的机构竞争所营造的不利环境所致。需要行业和医学界共同努力以改善这种状况。

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