Are explanatory trials ethical? Shifting the burden of justification in clinical trial design
Are explanatory trials ethical? Shifting the burden of justification in clinical trial design
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DOI：
10.1007/s11017-013-9262-4
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发表时间：
2013-08-01
影响因子：
1.4
通讯作者：
Borgerson, Kirstin
中科院分区：
文献类型：
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作者：
Borgerson, Kirstin
如今，大多数III期临床试验都是解释性的。由于解释性或有效性试验在“理想”条件下检验假设，因此它们不太适合在大多数临床护理环境中为决策提供指导。在“通常”条件下检验假设的实用主义试验通常更适合这项任务。然而，出于实用性或有效性的考虑，试验很少进行。临床试验的设计与卫生保健专业人员的需求之间的这种不匹配让每个参与者都感到沮丧，并解释了在试图加强知识转化和鼓励循证实践时所固有的一些挑战。然而，这种情况不仅仅是令人沮丧；这可能是不道德的。临床试验必须具有社会价值，以便：(1)保证它们对人类研究对象施加的风险；(2)公平有效地评估新的临床干预措施。大多数生物伦理学家都会同意，那些没有社会价值的试验，例如，因为它们的结果没有推进临床护理的潜力，就不应该进行。人们不太了解的是，在研究资源有限的情况下，在其他条件相同的情况下，应该优先选择社会价值更高的试验，而不是社会价值较低的试验。关于临床试验设计，我认为虽然解释性试验通常具有一定的社会价值，但许多试验的社会价值不如实用试验。基于这一普遍的伦理评估，我为临床研究人员应该致力于进行实用试验的立场提供了初步的辩护，也就是说，研究人员面临着与添加到试验设计中的任何理想化元素相关的辩护负担。
Most phase III clinical trials today are explanatory. Because explanatory, or efficacy, trials test hypotheses under "ideal" conditions, they are not well suited to providing guidance on decisions made in most clinical care contexts. Pragmatic trials, which test hypotheses under "usual" conditions, are often better suited to this task. Yet, pragmatic, or effectiveness, trials are infrequently carried out. This mismatch between the design of clinical trials and the needs of health care professionals is frustrating for everyone involved, and explains some of the challenges inherent in attempts to enhance knowledge translation and encourage evidence-based practice. The situation is more than simply frustrating, however; it is potentially unethical. Clinical trials must be socially valuable in order to (1) warrant the risks they impose on human research subjects and (2) fairly and efficiently assess new clinical interventions. Most bioethicists would agree that trials that have no social value, for instance, because their results do not have the potential to advance clinical care, should not be performed. What is less widely appreciated is that given limited research resources, trials that are more socially valuable should be preferred to trials that are less socially valuable when all else is equal. With respect to clinical trial design, I argue that while explanatory trials often have some social value, many have less social value than their pragmatic counterparts. On the basis of this general ethical assessment, I provide a preliminary defense of the position that clinical researchers should aim to conduct pragmatic trials, that is, that researchers face a burden of justification related to any idealizing elements added to trial designs.