创伤患者知情同意豁免试验中监管批准时间的分析
Analysis of time to regulatory approval in an exception from informed consent trial in trauma patients.
作者信息
Stephens Shannon W, Carroll-Ledbetter Christy R, Duckert Sarah, Coffman Tanner W, Nelson Margaret A, Rodgers Joel, Griffin Russell L, Grzyb Sarah, Suen Amy, Casey Jeremy, Sloan Steven R, Goldstein Brahm, Richwood Jay, Delfs Julia, McClintock Adam J, Gelinas Luke, Higley Amanda, Joseph Bellal, Holcomb John B, Jansen Jan O
机构信息
From the Department of Surgery (S.W.S., C.R.C.-L., S.D., T.W.C., M.A.N., J.R., J.B.H., J.O.J.), Center for Injury Science, and Department of Epidemiology (R.L.G.), University of Alabama at Birmingham, Birmingham, Alabama; Avania Clinical (S.G.), Marlborough, Massachusetts; CSL Behring (A.S., J.C., S.R.S., B.G., J.R., J.D.), King of Prussia, Pennsylvania; Office of Institutional Review Board (A.J.M.), University of Alabama at Birmingham, Birmingham, Alabama; Advarra (L.G., A.H.), Columbia, Maryland; and Department of Surgery (B.J.), University of Arizona, Tucson, Arizona.
出版信息
J Trauma Acute Care Surg. 2025 Mar 1;98(3):492-499. doi: 10.1097/TA.0000000000004465. Epub 2024 Oct 23.
BACKGROUND
The interactive media-based approach to community consultation and public disclosure (CC/PD), a key step when conducting exception from informed consent (EFIC) clinical trials, is intended to be completed in 4 months. This analysis characterizes the process, from initiation of CC/PD activities to institutional review board approval, to better understand the barriers and how these can be mitigated.
METHODS
This is a retrospective post hoc analysis of data collected as part of the CC/PD campaigns conducted for a large trial involving up to 90 trauma centers in the United States. Each site was provided with templated materials that had been reviewed and approved by a central institutional review board (cIRB). We collected the dates of milestones, including the study "kickoff call," start of the social media campaign, dates of online community meetings, date of submission of site report to the cIRB, and cIRB approval date.
RESULTS
Sixty-two sites were cIRB approved at the time of this analysis. The median time from the kickoff call to the start of the social media campaign was 79 days, with an interquartile range of 33 to 126 days (range, 0-285 days). All social media campaigns ran for the prescribed period of at least 2 months. All sites conducted at least four online community meetings. The median number of days from the kickoff call to cIRB approval was 216 days (interquartile range, 168-281 days; range, 116-459 days). There was no significant difference between sites that had previous experience of EFIC trials.
CONCLUSION
Using the interactive media-based approach, CC/PD can be completed quickly; however, there are barriers that can incur substantial delays. Greater harmonization of local administrative processes would shorten the time to conduct CC/PD activities and facilitate the timely commencement and execution of EFIC trials.
LEVEL OF EVIDENCE
Prognostic and Epidemiological; Level IV.
背景
基于互动媒体的社区咨询和公众披露（CC/PD）方法是进行知情同意豁免（EFIC）临床试验的关键步骤，预计在4个月内完成。本分析描述了从开展CC/PD活动到机构审查委员会批准的过程，以更好地了解障碍以及如何减轻这些障碍。
方法
这是一项回顾性事后分析，数据收集自为一项涉及美国多达90个创伤中心的大型试验开展的CC/PD活动。每个站点都收到了由中央机构审查委员会（cIRB）审查和批准的模板材料。我们收集了各个关键节点的日期，包括研究“启动电话会议”、社交媒体活动开始日期、在线社区会议日期、向cIRB提交站点报告的日期以及cIRB批准日期。
结果
在本次分析时，62个站点获得了cIRB批准。从启动电话会议到社交媒体活动开始的中位时间为79天，四分位间距为33至126天（范围为0至285天）。所有社交媒体活动均按规定持续了至少2个月。所有站点都至少召开了四次在线社区会议。从启动电话会议到cIRB批准的中位天数为216天（四分位间距为168至281天；范围为116至459天）。有EFIC试验经验的站点之间没有显著差异。
结论
使用基于互动媒体的方法，CC/PD可以快速完成；然而，存在可能导致大幅延迟的障碍。进一步统一当地行政流程将缩短开展CC/PD活动的时间，并促进EFIC试验的及时启动和执行。
证据水平
预后和流行病学；IV级。
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