目的:临床试验文件复杂,可能有不一致之处,导致潜在的现场实施错误,并可能危及参与者的安全。这项研究描述了在由集中的临床内容专家审查肿瘤学试验文件以进行临床试验实施期间进行的行政和潜在患者安全干预措施(PPSI)的频率和类型。
方法:一组专门的集中临床内容专家审查了试验文件,包括协议,实验室手册,和药房/细胞治疗手册,并收集1年期间的干预数据。每个试验按研究阶段和赞助者类型进行分类,每个试验可以确定多种干预措施.干预措施被视为行政或PPI,PPSI进一步细分为药物,实验室,程序相关,或其他。
结果:在审查的585项临床试验中,269(46%)需要干预。在1001项干预措施中,171(17.1%)为PPSI。大多数PPSI与药物相关(45.6%),最常识别的药物给药干预措施(53.8%)。与所有其他阶段相比,第一阶段试验的PPSI(0.35:1)和行政干预(2:1)比例最高。研究者发起的试验在所有申办者类型中每个试验的PPSI比例最高(0.44:1)。
结论:本研究表明,在评估临床试验实施的试验文件时,患者安全性存在差距。解决这一差距的一个解决方案是利用集中的临床专家团队来先发制人地审查试验文件。从而在临床试验过程中提高患者的安全性。
Clinical trial documents are complex and may have inconsistencies, leading to potential site implementation errors and may compromise participant safety. This
study characterizes the frequency and type of administrative and potential patient safety interventions (PPSIs) made during the review of oncology
trial documents for clinical
trial implementation by centralized clinical content specialists.
A dedicated group of centralized clinical content specialists reviewed trial documents, including the protocol, laboratory manual, and pharmacy/cellular therapy manual, and collected intervention data over a 1-year period. Each
trial was categorized by
study phase and sponsor type, and multiple interventions could be identified per
trial. Interventions were deemed administrative or PPSIs, with PPSIs further subcategorized as medication, laboratory, procedure related, or other.
Of 585 clinical trials reviewed, 269 (46%) required intervention(s). Among 1001 interventions, 171 (17.1%) were PPSIs. Most PPSIs were medication related (45.6%), with drug dosing interventions most frequently identified (53.8%). Phase 1 trials had the highest proportion of PPSIs (0.35:1) and administrative interventions (2:1) per trial compared with all other phases. Investigator-initiated trials saw the highest proportion of PPSIs per trial (0.44:1) of all sponsor types.
This
study demonstrates a gap in patient safety when assessing
trial documents for clinical
trial implementation. One solution to address this gap is the utilization of a centralized team of clinical specialists to preemptively review trial documents, thereby enhancing patient safety during clinical trial conduct.