Clinical research in Europe: Who do we do all that for?

被引:6
作者
Lacombe, Denis [1 ]
Golfinopoulos, Vassilis [1 ]
Negrouk, Anastassia [1 ]
Tombal, Bertrand [2 ]
机构
[1] EORTC, Brussels, Belgium
[2] Clin Univ St Luc, Brussels, Belgium
关键词
Clinical research; Treatment optimization; European regulations;
D O I
10.1016/j.jcpo.2020.100217
中图分类号
R19 [保健组织与事业(卫生事业管理)];
学科分类号
摘要
Independent applied clinical research addresses questions which are centered on optimization of treatments and patient management. It often finds itself confronted to policies and regulations implemented more specifically with pharmaceutical research and drug development in mind but which in practice apply throughout all clinical research programs. We report herein a specific case illustrating such challenges. We question how far legal constraints overshoot their initial objectives, leading to opposite effects for which they were set up. In an era where independent evaluation of cancer treatments is becoming so critical due to complexity, duplication and costs, comprehensive and pragmatic reform of our frameworks appears critical.
引用
收藏
页数:3
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