背景:1996年通过了知情同意例外(EFIC)规则,允许放弃某些紧急情况研究的知情同意,包括美国政府资助的试验。该规则要求患者或其合法授权代表(LAR)(如果可行)的预期同意。对于那些未经同意注册的人,患者或其LAR必须有机会尽早选择退出继续参与。我们试图对根据EFIC规则进行的试验进行普查,以促进研究,以更好地了解该规则的使用方式。
方法:我们进行了多管齐下的搜索,以确定根据EFIC规则进行的所有试验,借鉴评论,数据库搜索,检查FDA的文件,在IRB论坛上发布调查,并向所有已发表的EFIC试验和相关评论文章的主要作者发送电子邮件请求。我们描述了审判,当它们开始和完成时,以及他们是否被提前终止。
结果:截至4月底,我们共确定了110项试验,2022年:78完成,13招募,7在clinicaltrials.gov上注册,但尚未招募,在招募任何受试者之前被放弃的5项试验,和7项早期计划试验。78个已完成的试验中有9个是试点或可行性试验。在完成的69项全面审判中,30人(43.5%)提前终止。提前终止的最常见原因是徒劳(15项试验,25.0%),其次是招聘不力(10项试验,14.5%)。自2001年以来,试验的进行率一直保持不变,每5年开始约18项试验。
结论:我们已经编制了根据美国FDA的知情同意例外规则进行的试验普查,我们希望它的可用性将促进对这组试验的进一步深入数据收集和分析。
The exception from informed consent (
EFIC) rule was adopted in 1996, permitting waiver of informed consent for certain emergency research, including trials funded by the U.S. government. The rule requires prospective consent from patients or their legally authorized representative(s) (LAR) if practicable. For those enrolled without consent, the patient or their LAR must be given an opportunity to opt out from continued participation at the earliest opportunity. We sought to census the trials conducted under the
EFIC rule to facilitate research to better understand how the rule is being used.
We conducted a multipronged search to identify all trials conducted under the
EFIC rule, drawing on reviews, database searches, examination of the FDA\'s docket, posting an inquiry on the institutional review board forum, and email requests to lead authors of all published
EFIC trials and related review articles. We describe the trials, when they were started and completed, and whether they were terminated early.
We identified a total of 110 trials as of the end of April 2022: 78 complete, 13 recruiting, seven registered on clinicaltrials.gov but not yet recruiting, five trials that were abandoned before enrolling any subjects, and seven trials in early planning. Nine of the 78 completed trials were pilot or feasibility trials. Of 69 completed full trials, 30 (43.5%) were terminated early. The most common reason for early termination was futility (15 trials, 25.0%) followed by poor recruitment (10 trials, 14.5%). The rate of conduct of trials has been remarkably constant since 2001, with roughly 18 trials started in each 5-year period.
We have compiled a census of trials conducted under the U.S. FDA\'s
EFIC rule, the availability of which we hope will stimulate further in-depth data collection and analysis of this set of trials.