患者在临床试验中撤回同意后的数据保留。
Data retention after a patient withdraws consent in clinical trials.
作者信息
Gabriel André P, Mercado Charles P
机构信息
Department of Medicine, Columbia University Medical Center, New York, NY, USA.
出版信息
Open Access J Clin Trials. 2011 Apr;3:15-19. doi: 10.2147/OAJCT.S13960.
Abstract
Patient retention is critically important in the conduct of a successful clinical trial. The power in numbers in multicenter trials is dependent on the completion of follow-up for every patient randomized. If at the end of a clinical trial, a significant number of randomized patients are missing outcome data, there will not be enough pool for data analyses to conclude a study based on its primary and secondary objectives. When patients who are either lost to follow-up or who withdraw consent during the clinical trial are eliminated from the data pool, they subsequently affect the power and the validity of conclusions derived from the clinical study. This paper aims to present current guidance on data retention for patients who have withdrawn consent from clinical trials.
摘要
在成功开展临床试验的过程中，患者留存至关重要。多中心试验中人数的优势取决于对每一位随机分组患者的随访完成情况。如果在一项临床试验结束时，大量随机分组的患者缺失结局数据，那么就没有足够的数据池来基于主要和次要目标完成一项研究的数据分析。当在临床试验期间失访或撤回同意的患者从数据池中剔除后，他们随后会影响临床研究得出结论的效力和有效性。本文旨在针对已撤回临床试验同意书的患者提供有关数据留存的现行指导意见。
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