Competition between Science and Care in Clinical Trials

描述(由申请人提供)： 在实施临床试验(CT)时，临床研究人员面临着两套相互竞争的期望： 他们将忠实地执行研究方案，这是研究有效性所取决于的，并提供“患者”应得的临床护理。关于设计临床试验以服务于这两个目标的伦理问题，已经写了很多文章。然而，很少有人注意到研究临床医生如何在日常的基础上管理这些相互竞争的承诺。这项提案表明，在某些情况下，这些承诺之间的竞争可能会严重破坏《公约》的有效性。这项拟议的研究将对实施CT的工作人员和医生进行广泛的访谈，并在此之后对这些人进行全国调查。这项研究的目标是： 1.描述临床研究人员如何概念化他们对患者的临床护理的承诺以及他们对在CT中实施良好研究的承诺，以及他们是否认为这两项承诺之间存在竞争。 2.描述这种竞赛如何在不同的方法学领域(例如，招募、随机化)、研究设计和医疗情况下出现，以及临床研究人员认为在哪些情况下违反特定CT规则是合适的。 3.确定临床护理与高质量研究之间感觉到的冲突以及违反CT规则的频率。 4.确定违反CT规则的相关性，包括描述以下变量的变量：临床医生、试验设计、实验干预的性质和研究中的障碍。

DESCRIPTION (provided by applicant): In implementing clinical trials (CTs), clinician researchers face two competing sets of expectations: that they will faithfully implement the research protocol, on which the validity of the research depends, and provide the clinical care that "patients" deserve. Much has been written about the ethics of designing clinical trials so as to serve both goals. However little attention has been paid to how research clinicians manage these competing commitments on a day-to-day basis. This proposal suggests that there may be circumstances in which the competition between these commitments may seriously undermine the validity of the CT. The proposed study will do extensive interviews with staff and physicians who implement CTs and follow this with a national survey of such individuals. The goals of the study are to: 1. Describe how clinical researchers conceptualize their commitments to the clinical care of their patients and their commitments to implementing good research in CTs and whether they perceive competition between the two commitments. 2. Describe how this competition presents itself in different methodological domains (e.g., recruitment, randomization), study designs and medical situations and the circumstances in which clinical investigators feel it appropriate to violate the rules of the specific CT. 3. Ascertain the frequency of perceived conflicts between clinical care and quality research and of violations of rules of the CT. 4. Determine the correlates of violations of the rules of the CT including variables that describe: the clinicians, the design of the trial and the nature of the experimental intervention and the disorder under study.