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非注册试验中临床监测策略的制定与初步实施：来自ReStOre II试验的研究报告

Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.

作者信息

O'Neill Linda, Murphy Fiona, Reidy Derval, Poisson Camille, Hussey Juliette, Guinan Emer

机构信息

School of Medicine, Discipline of Physiotherapy, Trinity College, Dublin, Ireland.

Trinity St James's Cancer Institute, Trinity College, St James's Hospital, Dublin, Ireland.

出版信息

HRB Open Res. 2024 Oct 18;6:46. doi: 10.12688/hrbopenres.13763.2. eCollection 2023.

DOI:10.12688/hrbopenres.13763.2
PMID:39280895
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11401978/
Abstract

BACKGROUND

Data and Safety Monitoring is integral to quality assurance of clinical trials. Although monitoring is a core legal component of regulated clinical trials, non-regulated trials are not mandated to incorporate monitoring. Consequently, the monitoring process has been underutilised and underreported in this setting. This research report outlines the development and plans for implementing a bespoke Clinical Monitoring Strategy within the ' , a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors.

METHODS

This research note provides a detailed overview of the ReStOre II Clinical Monitoring Strategy and describes the development of the strategy pre and post awarding of the grant. The strategy consists of the establishment and implementation of a comprehensive trial governance structure, inclusive of a Trial Management Group, Trial Steering Committee Meeting, and Independent Data Monitoring Committee. In addition, external trial monitoring by the Clinical Research Facility at St James's Hospital. Three monitoring visits will be conducted during the trial; i) site initiation visit, ii) interim monitoring visit, and iii) close our visit.

RESULTS

The Clinical Monitoring Strategy has been finalised and is currently being implemented within the ReStOre II Trial. Two site initiation visits and one interim monitoring visit have been completed to date.

CONCLUSION

This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.

REGISTRATION

ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.

摘要

背景

数据与安全监测是临床试验质量保证不可或缺的一部分。尽管监测是受监管临床试验的核心法律组成部分，但非受监管试验并无强制要求纳入监测。因此，在这种情况下，监测过程未得到充分利用且报告不足。本研究报告概述了在“恢复II”试验（一项非受监管试验，在120名癌症幸存者队列中比较为期12周的多学科康复计划与标准护理）中实施定制临床监测策略的制定过程和计划。

方法

本研究报告详细概述了“恢复II”临床监测策略，并描述了在获得资助前后该策略的制定情况。该策略包括建立和实施全面的试验治理结构，包括试验管理小组、试验指导委员会会议和独立数据监测委员会。此外，由圣詹姆斯医院临床研究设施进行外部试验监测。试验期间将进行三次监测访问：i）试验启动访问，ii）中期监测访问，iii）结束访问。

结果

临床监测策略已最终确定，目前正在“恢复II”试验中实施。迄今为止，已完成两次试验启动访问和一次中期监测访问。

结论

本研究报告为在非受监管临床试验中实施临床监测策略提供了一个模板。

注册情况

“恢复II”试验：https://clinicaltrials.gov/ct2/show/NCT03958019 。