When and how to include vulnerable subjects in clinical trials.
When and how to include vulnerable subjects in clinical trials.
复制标题
何时以及如何在临床试验中包括弱势受试者。
DOI：
10.1177/1740774520945601
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Wendler D
中科院分区：
文献类型：
--
作者：
Wendler D
There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of 3 groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that IRBs can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.
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影响因子：
6.1
作者：
Piccoli, Giorgina Barbara;Minelli, Fosca;Todros, Tullia
通讯作者：
Todros, Tullia
影响因子：
168.9
作者：
Huang, Susan S.;Septimus, Edward;Platt, Richard
通讯作者：
Platt, Richard
影响因子：
2.2
作者：
Elger, Bernice S.;Spaulding, Anne
通讯作者：
Spaulding, Anne
DOI：
10.2979/fab.2008.1.2.5
发表时间：
2008-01-01
影响因子：
0.7
作者：
Lyerly, Anne Drapkin;Little, Margaret Olivia;Faden, Ruth
通讯作者：
Faden, Ruth
影响因子：
1.4
作者：
Kipnis, K
通讯作者：
Kipnis, K