{"title":"Development and Initial Implementation of a Clinical Monitoring Strategy in a Non-regulated Trial: a research note from the ReStOre II Trial.","authors":"Linda O'Neill, Fiona Murphy, Derval Reidy, Camille Poisson, Juliette Hussey, Emer Guinan","doi":"10.12688/hrbopenres.13763.2","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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 ' <i>Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial'</i>, a non-regulated trial comparing a 12-week multidisciplinary programme of rehabilitation to standard care in a cohort of 120 cancer survivors.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>This research note provides a template for implementation of a Clinical Monitoring Strategy in a non-regulated clinical trial.</p><p><strong>Registration: </strong>ReStOre II Trial: https://clinicaltrials.gov/ct2/show/NCT03958019.</p>","PeriodicalId":73254,"journal":{"name":"HRB open research","volume":"6 ","pages":"46"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11401978/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"HRB open research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.12688/hrbopenres.13763.2","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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 ' Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (ReStOre II) Trial', 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.
背景：数据与安全监控是临床试验质量保证不可或缺的一部分。尽管监查是受监管临床试验的核心法律组成部分，但不受监管的试验并不强制要求纳入监查。因此，在这种情况下，监测过程的利用率和报告率都很低。本研究报告概述了在 "食管胃癌和肝胰胆管癌术后康复策略（ReStOre II）试验 "中实施定制临床监控策略的发展和计划：本研究报告详细概述了 ReStOre II 临床监控策略，并介绍了该策略在获得资助前后的发展情况。该策略包括建立和实施全面的试验管理结构，其中包括试验管理小组、试验指导委员会会议和独立数据监控委员会。此外，圣詹姆斯医院的临床研究机构还将对试验进行外部监督。试验期间将进行三次监测访问：i) 现场启动访问；ii) 中期监测访问；iii) 结束访问：结果：临床监测战略已经确定，目前正在 ReStOre II 试验中实施。迄今为止，已完成两次现场启动考察和一次中期监测考察：本研究报告为在非规范临床试验中实施临床监测策略提供了一个模板：ReStOre II 试验：https://clinicaltrials.gov/ct2/show/NCT03958019。
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