Applying justice in clinical trials for diverse populations
Applying justice in clinical trials for diverse populations
复制标题
在针对不同人群的临床试验中应用正义
DOI：
10.1177/1740774507079440
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发表时间：
2007
期刊：
影响因子：
2.7
通讯作者：
J. Sugarman
中科院分区：
文献类型：
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作者：
J. Tilburt;J. Ford;M. Howerton;T. Gary;G. Lai;S. Bolen;C. Baffi;Renee F Wilson;T.P. Tanpitukpongse;N. Powe;E. Bass;J. Sugarman
背景相当多的注意力集中在增加“代表不足的群体”成员的临床试验参与度上。然而，这样做涉及澄清如何满足正义或公平的要求，这为加强广泛的审判代表提供了道德授权。目的研究公平的伦理原则，因为它适用于招募不同的人群参加临床试验。方法在本文中，我们分析了将公正原则应用于临床试验陈述所面临的概念和实践挑战。结果正义的不同方面包括对公平结果和公平过程的要求。在临床试验政策中包括这两个方面，不仅应该促进获得试验，而且还有助于提供一个框架，以提高临床试验代表性的公平性。评估招聘代表的工作应包括结果和程序措施。局限性基于这一概念分析提出的建议需要进行实证检验。结论参与临床试验设计、实施和监督的人员在评估临床试验的代表性时应考虑公正的所有方面，并试图在公平获得试验机会与公平程序之间取得平衡，因为公平程序可能需要保护，使其不会受到不适当的压力。临床试验2007年；4：264269；http://ctj.sagepub.com
Background Considerable attention has focused on increasing clinical trial participation for members of “underrepresented groups”. However, doing so involves clarifying how to meet the demands of justice, or fairness, which provides the ethical mandate to enhance broad trial representation. Purpose To examine the ethical principle of justice as it applies to recruiting diverse populations to clinical trials representation. Methods In this paper, we analyse the conceptual and practical challenges in applying the principle of justice to clinical trials representation. Results Different facets of justice include demands for both fair outcomes and fair processes. Including both of these facets in clinical trials policy should not only promote access to trials, but also help to provide a framework to improve fairness in representation in clinical trials. Efforts to evaluate recruitment of representation should include outcome and process measures. Limitations The suggestions offered based on this conceptual analysis need to be tested empirically. Conclusions Those involved in the design, conduct and oversight of clinical trials should consider all of the facets of justice when assessing representation in clinical trials and attempt to balance fair access to trials with a fair process that may require protection from being unduly pressured to participate. Clinical Trials 2007; 4: 264—269; http://ctj.sagepub.com