现场严重不良事件报告:一家三级医院伦理委员会的七年经验

Q2 Medicine
Y. Shetty, Prajakta D. Auti, Y. Aithal
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引用次数: 0

摘要

多年来,印度的法规经历了多次修订,包括严格的报告期限、关联性要求和严重不良事件(SAE)的赔偿义务。2019 年 3 月 19 日,印度提出了一项历史性变革--《新药和试验规则-2019》。本研究旨在确定各利益相关方是否按照不断变化的 SAE 标准进行报告。 2014年8月至2021年12月期间的数据在伦理委员会批准后进行了检索。2019 年 3 月 19 日之前收集的数据被归类为 "前 "数据,其余数据被归类为 "后 "数据。利用因果关系、现场 SAE 报告和伦理委员会审查程序,我们对合规性进行了评估。我们使用描述性统计对数据进行评估,并使用卡方检验或曼-惠特尼检验对 "前 "组和 "后 "组进行比较。 26 项临床试验共报告了 77 例 SAE,其中大多数临床试验为 III 期临床试验。内分泌项目占 9/26(34.61%)。在心脏病学研究中,SAE 分布最广的是 21 例/89 名参与者(23.59%),其中约 48% 是血管性的。AFTER "组注意到,SAE小组委员会会议的总数和时间长度均有所减少。在 "AFTER "组中,议程项目/会议的中位数明显增加(8 [4.5-10.75])(P < 0.0001)。然而,SAE 发生与首次报告日期之间的中位间隔仅为 1 天(四分位数间距:1-5 天)。在非死亡 SAE 中,支付的赔偿金没有显著差异。在 "AFTER "组中,报告 SAE 的时间没有差异。 对 SAE 报告标准的遵守情况可以接受。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Onsite serious adverse events reporting: Seven-year experience of the institutional ethics committee of a tertiary care hospital
Over the years, Indian regulations have undergone numerous amendments, including stringent reporting deadlines, relatedness requirements, and compensation obligations for serious adverse event (SAE). A historic change, new drugs and trial rules-2019, was proposed on March 19, 2019. The purpose of the study was to ascertain whether various stakeholders were reporting in accordance with the evolving SAE criteria. Data were retrieved after the Ethics Committee’s approval between August 2014 and December 2021. Data gathered before March 19, 2019, were categorized as “BEFORE” data, while the remaining data were categorized as “AFTER.” Utilizing causality, on-site SAE reporting, and the ethics committee review procedure, we evaluated the compliance. The data were evaluated using descriptive statistics, and the Chi-square or Mann–Whitney tests were used to compare the “BEFORE” and “AFTER” groups. A total of 77 SAEs were reported in 26 clinical trials, where most clinical trials were phase III. Endocrine projects made up 9/26 (34.61%). In the cardiology studies, the greatest SAE distribution was 21 SAEs/89 participants (23.59%) with approximately 48% of these being vascular. The “AFTER” group noticed a decrease in the total number and length of SAE subcommittee meetings. In the “AFTER” group, there was a significantly higher median number of agenda items/meetings (8 [4.5–10.75]) (P < 0.0001). The median interval between the onset of SAE and the first reporting date, however, was just 1 day (interquartile range: 1–5 days). In nondeath SAEs, there was no significant difference in the compensation paid. In the “AFTER” group, there were no discrepancies in reporting SAE. There is acceptable adherence to SAE reporting criteria.
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来源期刊
Perspectives in Clinical Research
Perspectives in Clinical Research Medicine-Medicine (all)
CiteScore
2.90
自引率
0.00%
发文量
41
审稿时长
36 weeks
期刊介绍: This peer review quarterly journal is positioned to build a learning clinical research community in India. This scientific journal will have a broad coverage of topics across clinical research disciplines including clinical research methodology, research ethics, clinical data management, training, data management, biostatistics, regulatory and will include original articles, reviews, news and views, perspectives, and other interesting sections. PICR will offer all clinical research stakeholders in India – academicians, ethics committees, regulators, and industry professionals -a forum for exchange of ideas, information and opinions.
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