Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports

Autor: Bernabe, Rosemarie de la Cruz, van Thiel, GJMW, Breekveldt, NS, Gispen-de Wied, CC, Van Delden, Johannes JM

Publikováno v: Bernabe, Rosemarie de la Cruz van Thiel, GJMW Breekveldt, NS Gispen-de Wied, CC Van Delden, Johannes JM . Ethics in clinical trial regulation: ethically relevant issues from EMA inspection reports. Current Medical Research and Opinion. 2018, 1-9
Current Medical Research and Opinion

Externí odkaz: http://hdl.handle.net/10852/71900
https://www.duo.uio.no/bitstream/handle/10852/71900/4/Full%2Bversion.pdf

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Randomized controlled clinical trials (RCTs) are considered fundamental to the optimization of health care decision-making. Today, the drug development and evaluation process is dominated by so-called explanatory RCTs. Such RCTs are carried out in hi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=dedup_wf_001::a88d0a1d4c478156a59f63f398a5e8c9
https://dspace.library.uu.nl/handle/1874/345859

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