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.

这个研究是关于什么的？该研究奖学金旨在开发改进临床试验设计和实施的方法。它将专门研究人们的行为（他们做什么以及如何）如何影响临床试验的成功，以及我们可以采取哪些措施来改善这一点。为什么要开展这个项目？临床试验是我们比较治疗方法的主要科学方法，以显示哪种治疗方法更好。所谓“治疗”，我们可以指药物、手术、器械（例如导管）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（患者或医疗保健专业人员）做一些与他们通常所做的不同的事情，例如为患者服用新的片剂或医生与患者谈论参加临床试验。执行或不执行这些任务可能会影响临床试验的整体成功。如果人们不能很好地执行这些任务，这可能会导致临床试验不能很好地执行（在某些情况下可能导致临床试验失败），这既浪费金钱，也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”--它们都涉及做一些事情。可以在试验的每个阶段识别相关行为，从建立和招募到交付的所有阶段，并对其进行优化，以便改善临床试验的运行。这就是本研究方案的目的。它将使用行为科学-行为和行为变化的学术研究-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提供临床试验所涉及的所有步骤，并确定其中哪些步骤包括行为。在第一阶段，我们还将寻找现有的研究，看看其他研究人员是否以及如何在使用这种行为视角之前分析试验中的问题。2.第二阶段将制定方法，帮助确定试验中造成问题的行为（例如，人们没有返回问卷），并提供解决方案以帮助解决这些问题。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，例如通过使用调查和访谈来帮助识别是什么使特定行为变得容易或更加困难。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，并提供如何改进这些行为的指导。我们将免费提供这些工具，并向他们提供“如何”指南，以便其他团队知道如何以及何时将其应用于他们的研究中以进行改进。为了鼓励全球采用这一方法，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。谁参与了项目的设计？我已经咨询了广泛的专家关于如何最好地设计这项研究。公众、设计和提供临床试验的人、心理学家、卫生保健专业人员和工业界都参与了进来，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以不同的方式、何时以及如何做什么来改变试验团队交付临床试验的方式。这项研究的承诺是对试验的重大改进，从使用更好的方法为每年参与的数百万患者设计和进行更好的试验。