在临床试验的设计和执行中,技术在避免偏倚方面的作用

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
H. Goodale, D. Mcentegart
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引用次数: 1

摘要

通讯:Hazel Goodale Perceptive Informatics Inc, Lady Bay House, Meadow Grove, Nottingham, NG2 3HF, uk Tel +44 115 844 3962 Fax +44 115 955 7555 Email hazel.goodale@perceptive.com摘要:有许多文献记载的偏倚对临床试验结果产生不利影响的例子。这导致了一些设计技术的发展,可以在临床试验中实施,以减少偏倚。对已发表的案例研究的偏倚来源进行审查和讨论。概述了技术在减轻偏倚方面的潜在用途,特别是使用集中的互动反应系统对患者进行随机分组,并以这样一种方式管理药物,以限制因了解患者当前治疗或未来治疗任务而导致的偏倚风险。潜在的偏倚来源包括选择偏倚、偶然偏倚、评估偏倚、观察者偏倚和操作偏倚。这些可能是由于试验过程中不充分的随机化和隐瞒方法造成的。在频繁调整剂量的研究中,可以通过个别代码的中断或通过推导来打破盲法;在适应性试验中有推演的余地,这也可能引入偏见。技术可以通过多种方式减少或消除潜在的偏倚,包括中心随机化和安全方法,以保护盲法和试验的完整性。然而,如果由于技术的使用而使随机化和配药分离成为可能,则不能正确应用,那么可以引入新的解盲方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The role of technology in avoiding bias in the design and execution of clinical trials
Correspondence: Hazel Goodale Perceptive Informatics Inc, Lady Bay House, Meadow Grove, Nottingham, NG2 3HF, United Kingdom Tel +44 115 844 3962 Fax +44 115 955 7555 Email hazel.goodale@perceptive.com Abstract: There are many documented instances in which bias has had an adverse effect on the results of clinical trials. This has led to a number of design techniques being developed that can be implemented in clinical trials in order to reduce bias. Sources of bias referring to published case studies are reviewed and discussed. The potential uses of technology to alleviate bias are outlined, particularly the use of centralized interactive response systems to randomize patients and manage medication in such a way as to limit the risk of bias caused by knowledge of either a patient’s current treatment or future treatment assignments. Potential sources of bias include selection bias, accidental bias, assessment bias, observer bias, and operational bias. These can arise through inadequate randomization and concealment methods during the trial. The blind may be broken by individual code breaks or through deduction in studies with frequent dose adjustments; there is scope for deduction in adaptive trials that might also introduce bias. Technology can reduce or eliminate the potential for bias in a variety of manners including central randomization and secure methods to protect the blinding and trial integrity. However, if the separation of randomization and dispensing, made possible by the use of technology, is not applied correctly then new unblinding scenarios can be introduced.
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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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