Behavioural Optimisation and Operational Strategies for Trials: The BOOST Approach
Lead Research Organisation:
University of Aberdeen
Department Name: Sch of Medicine, Medical Sci & Nutrition
Abstract
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 creating
problems (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.
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 creating
problems (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.
Technical Summary
My vision is to improve health by transforming the design and delivery of clinical trials through the development of innovative interdisciplinary behavioural optimisation methodology that will allow trials to deliver more robust patient focussed findings. Clinical trials are expensive and often fail to deliver on their promise due to problems with trial conduct, namely recruitment and retention. The conduct of trials involves behaviours, in other words, they rely on people (patients, clinicians, trial staff) performing, or not, an action such as approaching eligible participants or returning a questionnaire. These trial related behaviours are pervasive, contextually determined, and amenable to change. Indeed, a failure to recognise behavioural influences (and change them where appropriate) could contribute to the trials overall success or failure. This is where the behavioural optimisation methodology will add value through addressing the following research objectives:
a. Determine which components of trials can be considered through a behavioural lens
b. Investigate how behavioural approaches have been applied to the conduct of trials to date
c. Identify core behavioural components on influences and interventions targeting trial conduct
d. Establish the feasibility of the application of a behavioural approach to the conduct of trials
e. Critically consider the ethical issues relevant when applying a behavioural approach to trial conduct
f. Identify what resources trial teams need to adopt behaviourally focussed approach to conducting trials
g. Establish an international network to engage research communities and promote wide adoption and future opportunities.
My programme of research has the potential to generate a step change in the way teams conduct clinical trials. It will build bridges across disciplines and apply evidence based practices that translate to demonstrable enhancements in clinical trials for all-improving health by improving research.
a. Determine which components of trials can be considered through a behavioural lens
b. Investigate how behavioural approaches have been applied to the conduct of trials to date
c. Identify core behavioural components on influences and interventions targeting trial conduct
d. Establish the feasibility of the application of a behavioural approach to the conduct of trials
e. Critically consider the ethical issues relevant when applying a behavioural approach to trial conduct
f. Identify what resources trial teams need to adopt behaviourally focussed approach to conducting trials
g. Establish an international network to engage research communities and promote wide adoption and future opportunities.
My programme of research has the potential to generate a step change in the way teams conduct clinical trials. It will build bridges across disciplines and apply evidence based practices that translate to demonstrable enhancements in clinical trials for all-improving health by improving research.
People |
ORCID iD |
| Kate Gillies (Principal Investigator / Fellow) |