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.

这项研究是什么？这项研究奖学金旨在开发改善临床试验设计和行为的方法。它将特别研究人们的行为（他们做什么以及如何影响临床试验的成功以及我们可以改善这一问题的成功）。为什么这个项目？临床试验是我们比较治疗方法的主要科学方法，以表明哪个更好。通过“治疗”，我们可能是指药物，手术，设备（例如导管）或物理或心理疗法。每年数以百万计的患者参加临床试验。临床试验通常要求人们（患者或医疗保健专业人员）做一些与他们通常所做的事情不同的事情，例如为患者服用新平板电脑或与患者进行临床试验的医生对话。执行或不执行这些任务可以很好地影响临床试验的整体成功。如果人们不像他们那样执行这些任务，这可能会导致临床试验的表现不佳（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所投入的时间和精力。这些任务被称为“行为” - 它们都涉及做某事。可以在试验的每个阶段，从各个阶段进行设置和招聘，并优化它们，以便改善临床试验的运行，从而确定相关行为。这是该研究计划的目的。它将使用行为科学 - 行为和行为改变的学术研究 - 帮助阐明临床试验中的行为，并帮助改善如何完成临床试验。该研究将如何进行？研究具有三个关键阶段。1。第一阶段将详细说明提供临床试验的所有步骤，并确定以下哪些步骤包括行为。在第一阶段，我们还将寻找现有的研究，以查看其他研究人员在使用这种行为观点之前是否已经分析了试验中的问题。 2。第二阶段将开发方法，以帮助确定正在创建问题的试验中的行为（例如，人们不返回问卷）并提供解决方案来帮助解决方案。我们将处理即将或最近开始的临床试验。在这些临床试验中，我们将研究使用行为方法来识别问题的方法，例如，使用调查和访谈可以帮助确定使特定行为变得容易或更加困难的方法。 3。在最后阶段，我们将开发研究工具，以帮助临床试验团队在自己的试验中确定行为，并提供有关如何改善它们的指南。我们将免费提供这些工具，并为它们提供“ HOFOW”指导，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。为了鼓励在全球范围内采用这种方法，我们将开发一个对这一领域感兴趣的研究人员网络，并为学习，共享经验和进一步的研究提供机会。谁参与了该项目的设计？我已经与众多专家咨询了如何最好地设计这项研究。公众，设计和提供临床试验，心理学家，卫生保健专业人员和行业的人已经参与其中，并将继续就该项目提供建议。如何使用这项研究的结果？我提出的研究计划有可能在试验团队进行临床试验的方式中产生逐步变化，以解决谁需要对谁进行不同，何时以及如何做的事情。这项研究的承诺是，从使用更好的方法来设计和进行更好的试验的试验的重大改进，为每年参加的数百万患者进行更好的试验。