Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials
Empirical assessment of whether moderate payments are undue or unjust inducements for participation in clinical trials
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DOI：
10.1001/archinte.164.7.801
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发表时间：
2004-04-12
影响因子：
--
通讯作者：
Asch, DA
中科院分区：
文献类型：
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作者：
Halpern, SD;Karlawish, JHT;Asch, DA
背景：付钱让患者参加临床试验在伦理上是有争议的。然而，关于付款是否代表不正当或不公正的引诱，没有经验文件。方法：为了评估这些问题，我们对一种新型降压药的假设安慰剂对照试验进行了描述，该试验从一所大学医院的高血压和普通医学诊所招募了126名轻中度高血压患者。使用3 × 3的受试者内设计，我们改变了参与的风险（不良反应率或安慰剂随机化率）和参与者将获得的报酬（100美元、1000美元和2000美元），并要求患者使用6分制表示他们在每个试验中的参与意愿（WTP）。结果：聚类有序logistic回归模型显示，患者WTP随不良反应风险的增加而降低(P
Background: Paying patients to participate in clinical trials is ethically controversial. However, there has been no empirical documentation regarding whether payment represents an undue or unjust inducement.Methods: To evaluate these questions, we described hypothetical placebo-controlled trials of a new antihypertensive drug to 126 patients with mild-to-moderate hypertension recruited from hypertension and general medicine clinics at a university hospital. Using a 3x3, within-subjects design, we altered a risk to participation (either adverse effect rate or rate of randomization to placebo) and the payment participants would receive ($100, $1000, and $2000) and asked patients to indicate their willingness to participate (WTP) in each trial using a 6-point scale.Results: Clustered ordinal logistic regression models revealed that patients' WTP decreased with higher risk of adverse effects (P