Learning from OCTET - exploring the acceptability of clinical trials management methods
Learning from OCTET - exploring the acceptability of clinical trials management methods
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DOI：
10.1186/s13063-018-2765-6
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发表时间：
2018-07-13
期刊：
影响因子：
2.5
通讯作者：
Gellatly, Judith
中科院分区：
文献类型：
--
作者：
Arundel, Catherine;Gellatly, Judith
背景：进行研究可能是耗时、困难和具有挑战性的。针对随机对照试验行为的指导和实用建议是可用的，但不一定构成全面的指导。一项成功的试验是在最初商定的预算内，按照时间和目标招募人员，并收集高质量的数据。标准化的试验管理工具概述了成功试验的关键项目管理要素，以此作为确保研究试验良好做法的一种方法：启动、规划、执行、监测和结束。在试验的开发和实施过程中也经常吸取经验教训，但很少分享给其他人。对于更广泛的研究团队来说，关键的重点始终是研究的执行和交付。本研究的目的是评估国家卫生研究院卫生技术评估计划资助的强迫症治疗疗效试验(OCTET)中实施的临床试验管理方法的可接受性，重点是研究的执行和监测。方法：采用研讨会、问卷调查和半结构访谈的方式，探讨OCTET试验研究团队成员对试验管理方法的可接受性。9名成员参加了焦点小组，10名成员完成了问卷调查，20名成员接受了访谈，作为主要八重奏研究的定性工作的一部分。结果：确定了六个关键主题：支持、沟通、过程、资源、培训和精神。审判管理人员和首席调查员的明确和开放的沟通、热情和可及性一直被认为是审判成功进行的一个重要方面。明确的资源和培训材料也被认为是帮助工作人员在审判环境中工作的关键。还提出了改进这些资源的建设性建议；例如，包括试验过程中的清单和流程图。结论：组织、公开和积极是成功执行试验的关键，而明确和集中的过程和资源对于监测和控制试验进展至关重要。虽然这些发现来自单一研究，但很可能适用于所有试验的成功进行。试验经理在建立一项研究时应考虑发展这些要素。
Background: Conducting research can be time consuming, difficult and challenging. Guidance and pragmatic advice focussing on randomised controlled trial conduct are available but do not necessarily constitute comprehensive guidance. A successful trial is one that recruits to time and target and collects high-quality data within the originally agreed budget. Standardised trial management tools have outlined key project management elements for a successful trial as a method of ensuring good practice in research trials: initiation, planning, execution, monitoring and closure. Lessons are also frequently learnt during the development and conduct of trials but rarely shared for the benefit of others.For the wider research team, the key focus will always be on the execution and delivery of a study. The aim of this study was to evaluate the acceptability of clinical trials management methods, focussing on study execution and monitoring, as implemented in the National Institute for Health Research Health Technology Assessment Programme-funded Obsessive Compulsive Treatment Efficacy Trial (OCTET).Methods: Workshops, questionnaires and semi-structured interviews were used to explore acceptability of trial management methods with members of the OCTET Trial research team. Nine members participated in the focus group, 10 completed a questionnaire and 20 were interviewed as part of qualitative work for the main OCTET study. Data was collected and analysed using thematic analysis.Results: Six key themes were identified: support; communication; processes; resources; training and ethos. Clear and open communication, enthusiasm and accessibility of the trial managers and chief investigator were consistently noted as an important facet of the successful running of the trial. Clear resources and training materials were also found to be crucial in helping staff to work within the trial setting. Constructive suggestions were also made for improvement of these resources; for example, including both checklists and flowcharts within trial processes.Conclusion: Organisation, openness and positivity are crucial for executing a trial successfully, whilst clear and focussed processes and resources are essential in monitoring and controlling the trial progress. Although derived from a single study, these findings are likely to be applicable to the successful conduct of all trials. Trial managers should consider developing these elements when setting up a study.