Thank you to Lloyd for allowing yet another highjack of his weekly blog! We have heard in previous blogs about ongoing developments with the MAHSC Trials Co-ordination Unit, and I’m sure there is much more to come on that topic in the next few months. But this week, we want to highlight another important strength of clinical trials within Manchester: research into the underpinning methodology of trials.
The design, conduct and analysis of a clinical trial is sometimes (incorrectly) thought to be a resolved issue, belonging in a dusty textbook and unchanged since Austin Bradford Hill started using random allotment of Streptomycin in 1948. Simply select the appropriate design to answer your question, work out the sample size needed and away you go.
In fact, there is a huge amount of active research in this area. To name but a few: statisticians are working on methods to analyse the data that mean fewer people need to be recruited at the start of the study; health services researchers are developing a science of recruitment, testing different approaches to see what encourages patients to participate; and informaticians are developing infrastructure to access electronic health records to conduct ‘real-world’ pragmatic trials.
This was recognised by the Medical Research Council (MRC) in 2008 when it funded the MRC Network of Hubs for Trials Methodology Research (HTMR). Since 2013, it has supported five Hubs across the UK, including the MRC North West Hub for Trials Methodology Research (NWHTMR), which involves the Universities of Manchester, Liverpool, Lancaster and Bangor. Groups in the Institute of Population Health at The University of Manchester play a leading role in the NWHTMR and the wider network.
The trials research in Manchester focuses on three key areas:
Efficacy and mechanisms evaluation (EME) – led by Dr Richard Emsley
This programme answers the following questions about treatments:
- Does it work? – is there a beneficial effect of the treatment compared to some other treatment, or treatment as usual?
- How does it work? – what are the underlying mechanisms or targets of the treatment?
- Who does it work for? – are there subgroups of people who benefit most? Could the treatment be targeted to particular subgroups of the population?
- What factors make it work better? – is the intervention more effective when delivered as intended, or when the alliance with the clinician is strong?
This programme ensures that the design and conduct of trials over their entire lifecourse is informed by evidence on the perspectives of patients by:
- Recruitment to and retention in trials – studying participants’ experiences to improve the evidence-base concerning recruitment to trials, enhance recruitment rates and make research more accessible to the public;
- Outcome measurement – both patient-reported outcome measures (PROMS) and patient perspectives on outcome measures e.g., generation of core outcome sets by patients;
- Processes and outcomes of patient involvement – in the design and execution of trials, including the feasibility and impact of different models of user involvement.
Traditional trials typically deal with structured data collection at predefined intervals, with information collected specifically for a trial. The increasing amount of digital data being collected (such as sensing devices, phone apps such as ClinTouch or electronic health records) will change data collection processes but also the methodologies to analyse these data. This programme, which is also a theme of the MRC Health eResearch Centre, is looking at methods to:
- Enhance recruitment feasibility assessments – investigating a variety of systems and available data to improve current approaches to recruitment feasibility assessments, including Clinical Practice Research Datalink, NIHR portfolio, and FARSITE (Feasability Assessment and Recruitment System for Improving Trial Efficiency).
- Optimise data collection – evaluating the practicality of using routinely collected clinical data in trials, exploring the hypothesis that trials would be easier to run if the main outcomes are collected routinely.
In the autumn, we will be holding a series of events to mark the founding of a new virtual network for the Hub, Trials@Manchester, to bring together researchers across MAHSC partners and the local region who have an interest in trials methodology. This network aims to: 1) promote awareness of clinical trials methodology research in Manchester; 2) promote clinical engagement with the NWHTMR and; 3) secure significant future MRC/NIHR investment in clinical trials research in Manchester.
One of these events is an on-campus training course for investigators aimed at health and research professionals, particularly those aiming to become Chief Investigators in the near future. It is taking place on 14-18 September, and further details are available here.
In the meantime, if you would like to know more about the MRC NWHTMR trials methodology research in Manchester or any of the specific research areas highlighted above, we would be delighted to talk to anyone who is interested, so please contact one of us via the links above.