The unique status of first-in-human studies: strengthening the social value requirement

Habets Michelle G. J. L.; van Delden Johannes J. M.; Bredenoord Annelien L.

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The unique status of first-in-human studies: strengthening the social value requirement

机译：首次研究的独特状况：加强社会价值要求

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For clinical research to be ethical, risks need to be balanced by anticipated benefits. This is challenging for first-in-human (FIH) studies as participants are not expected to benefit directly, and risks are potentially high. We argue that this differentiates FIH studies from other clinical trials to the extent that they should be given unique status in international research ethics guidelines. As there is a general positive attitude regarding the benefits of science, it is important to establish a more systematic method to assess anticipated social value to safeguard participants not only from enrolling in risky, but also in futile trials. Here, we provide some of necessary steps needed to assess the anticipated social value of the intervention.

机译：对于临床研究是道德的，需要通过预期的益处平衡风险。这是一个挑战，因为参与者预计不会直接受益，风险潜在高。我们认为，这种临床试验的FIH研究区别于他们应该在国际研究道德准则中获得独特地位的程度。由于对科学效益存在一般的积极态度，重要的是建立一种更系统的方法，以评估预期的社会价值，不仅征收风险，而且还在徒劳的试验中。在这里，我们提供了一些必要的步骤，以评估介入的介入的预期社会价值。

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《Drug discovery today》 |2017年第2期|共5页
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Habets Michelle G. J. L.; van Delden Johannes J. M.; Bredenoord Annelien L.;
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Univ Med Ctr Utrecht Julius Ctr Primary Care &

Hlth Sci Dept Med Humanities Heidelberglaan 100;

Univ Med Ctr Utrecht Julius Ctr Primary Care &

Hlth Sci Dept Med Humanities Heidelberglaan 100;

Univ Med Ctr Utrecht Julius Ctr Primary Care &

Hlth Sci Dept Med Humanities Heidelberglaan 100;

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正文语种 eng
中图分类药学;
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The unique status of first-in-human studies: strengthening the social value requirement

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