Behavioural Optimisation and Operational Strategies for Trials: The BOOST Approach

试验的行为优化和操作策略：BOOST 方法

• 批准号: MR/X007464/1
• 负责人: Kate Gillies
• 金额: $ 215.02万
• 依托单位: University of Aberdeen
• 依托单位国家: 英国
• 项目类别: Fellowship
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FX007464%2F1
• 关键词: Behavioural; Optimisation; Operational; Strategies; Trials

What is this research about?This research fellowship aims to develop methods to improve the design and conduct of clinical trials. It will specifically look at how people's behaviours (what they do and how) affect the success of clinical trials and what we can do to improve this.Why this project?Clinical trials are the main scientific way we compare treatments in order to show which is better. By 'treatment' we could mean a drug, or an operation, a device (e.g. a catheter) or a physical or psychological therapy. Millions of patients take part in clinical trials every year. Clinical trials often ask people (patients or healthcare professionals) to do something different to what they would normally do e.g. take a new tablet for a patient or for a doctor talk to their patient about taking part in a clinical trial. Performing, or not performing, these tasks well can impact on the overall success of the clinical trial. If people don't perform these tasks as well as they might, this can lead to clinical trials not performing as well as they might (and in some cases may lead to the clinical trial failing) which is both a waste of money and also a waste of the time and effort the patients and staff have put into them. These tasks are known as "behaviours" - they all involve doing something. It is possible to identify relevant behaviours at every stage of a trial, from set up and recruitment through all stages of delivery, and to optimise them so that the running of the clinical trial could be improved. This is the aim of this programme of research. It will use behavioural science - the academic study of behaviour and behaviour change - to help shed light on behaviours in clinical trials and help improve how clinical trials are done.How will the research be done?The research has three key phases.1. The first phase will detail all the steps involved in delivering a clinical trial and identify which of these steps include behaviours. During this first phase we will also look for existing research to see whether and how other researchers have analysed problems in trials before using this behaviours perspective. 2. The second phase will develop methods to help identify behaviours in trials that are creatingproblems (e.g. people not returning a questionnaire) and provide solutions to help address them. We will work with clinical trials that are about to or have recently started. In these clinical trials we will investigate ways of identifying problems using behavioural approaches, for example by using surveys and interviews that can help identify what makes a particular behaviour easy or more difficult. 3. In the final phase, we will develop research tools to help clinical trial teams identify behaviours in their own trials and provide guides on how they can improve them. We will make these tools freely available and present them with a 'how to' guide such that other teams know how and when to apply them in their studies to make improvements. To encourage the uptake of this approach globally, we will develop a network of researchers interested in this area and provide opportunities for learning, sharing experiences, and further research.Who has been involved in the design of the project?I have consulted with a wide range of experts about how best to design this research. Members of the public, people who design and deliver clinical trials, psychologists, health care professionals, and industry have been involved and will all continue to advise on the project. How will the results of this research be used?My proposed programme of research has the potential to generate a step-change in the way trial teams deliver clinical trials by addressing who needs to do what differently to whom, when and how. The promise of this research is the major improvements to trials from using better methods to design and conduct better trials for the millions of patients who participate every year.

这项研究是关于什么的？本研究奖学金旨在发展方法，以改善临床试验的设计和实施。它将特别关注人们的行为（他们做了什么以及如何做）如何影响临床试验的成功，以及我们可以做些什么来改善这一点。为什么要做这个项目？临床试验是我们比较治疗的主要科学方法，以表明哪种治疗更好。所谓“治疗”，我们可以指药物、手术、设备（如导管）或物理或心理治疗。每年有数百万患者参加临床试验。临床试验通常要求人们（病人或医疗保健专业人员）做一些与他们通常做的不同的事情，例如，为病人服用一种新的药片，或者让医生告诉病人参加临床试验。完成或不完成这些任务会影响临床试验的整体成功。如果人们不能很好地完成这些任务，这可能会导致临床试验表现不佳（在某些情况下可能会导致临床试验失败），这既是浪费金钱，也是浪费患者和工作人员投入的时间和精力。这些任务被称为“行为”——它们都需要做一些事情。有可能在试验的每个阶段确定相关行为，从建立和招募到交付的所有阶段，并优化它们，以便临床试验的运行可以得到改善。这就是这个研究项目的目的。它将使用行为科学——对行为和行为改变的学术研究——来帮助阐明临床试验中的行为，并帮助改进临床试验的进行方式。研究将如何进行？本研究分为三个关键阶段。第一阶段将详细说明进行临床试验所涉及的所有步骤，并确定哪些步骤包括行为。在第一阶段，我们还将寻找现有的研究，看看其他研究人员在使用这种行为视角之前是否以及如何分析试验中的问题。2. 第二阶段将开发方法来帮助识别在试验中产生问题的行为（例如，人们不返回问卷），并提供解决方案来帮助解决这些问题。我们将与即将或最近开始的临床试验合作。在这些临床试验中，我们将研究使用行为方法识别问题的方法，例如通过调查和访谈来帮助识别使特定行为容易或困难的因素。3. 在最后阶段，我们将开发研究工具，帮助临床试验团队识别他们自己试验中的行为，并为他们如何改进这些行为提供指导。我们将免费提供这些工具，并提供“如何使用”指南，以便其他团队知道如何以及何时将它们应用于他们的研究以进行改进。为了鼓励全球采用这种方法，我们将建立一个对这一领域感兴趣的研究人员网络，并提供学习、分享经验和进一步研究的机会。谁参与了这个项目的设计？关于如何最好地设计这项研究，我咨询了很多专家。公众、设计和实施临床试验的人、心理学家、卫生保健专业人员和业界人士都参与其中，并将继续为该项目提供建议。这项研究的结果将如何使用？我提出的研究计划有可能通过解决谁需要对谁、何时以及如何做不同的事情来改变试验团队进行临床试验的方式。这项研究的前景是通过使用更好的方法来设计和实施更好的试验，为每年数百万参加试验的患者提供重大改进。