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International Clinical Trials Day, held this year on the 20th May, marks the anniversary of the start of James Lind’s famous trial into the causes of scurvy in 1747. The NIHR will mark the day with an 'OK to ask' campaign, calling on patients and carers to ask their doctor about NHS research they can take part in.

Re considering the way we design and deliver trials

The NIHR School for Primary Care Research (SPCR) has a long history of funding and supporting trials in primary care and has supported over 80 studies including in the areas of infection, heart and kidney disease, musculoskeletal disorders, diabetes, patient-centred care, cancer, depression, multimorbidity and e-health.

We spoke to SPCR trainee Claire Planner (Research Associate [1]) and Ailsa Donnelly (Patient and Public Involvement Partner) from the University of Manchester about their new programme of work- PACT  - which explores the concept of the ‘patient-centred trial’.

What is the difference between clinical care and trials in terms of defining patient-centeredness?

Claire: The million dollar question! There is no ‘official’ definition of what patient-centredness means in the context of trials (we’re working on that). If we borrow definitions commonly used for clinical care, it’s about seeing the process ‘through the eyes of the patient’ and ‘being responsive to patient needs’.

What prompted your interest in patient-centred trials methodology?

Ailsa: Having experienced trials from both sides (i.e. both as a participant and through my role as a PPI partner) I was frustrated that so many failed to consider the participant perspective. For example, they would ask those with urge incontinence to travel to clinics for tests which could be done at home; or appointments for mothers of primary school age children would be arranged between 4 and 6pm. Much of it is a matter of respect – you are asking people to give something – anything from control of their treatment to time. Surely you should make it as easy as possible for them?

Claire: It’s time to reconsider the way we design and deliver trials – and to put patients and the public at the centre of that work. But it is going to take a change in mind-set amongst academics. We need to find out what is going on behind those CONSORT diagrams. We need to ask patients how they experience the trials process from beginning to end - from the first time they hear about a trial to the end when the results are- hopefully- shared.

What does your research look at?

Claire: We have four key objectives for the PACT programme: to define what we mean by a patient-centred trial, to explore how we can measure experience of trial participation, to develop guidance and standards for trial design and delivery, and to collaborate with patients and the public in achieving all of these goals.

These goals were agreed amongst stakeholders after two really thought-provoking workshops held in 2014. We have summarised the discussions in a report available for download from the PACT website. I’ve also recently conducted a scoping review of trial experience measures and found that the trials community is not asking participants about their experience of taking part in any consistent way- a real missed opportunity.  

Why is your research into patient-centred trials methodology relevant?

Ailsa: It’s important for all sides (patients, health researchers, the SPCR and NIHR) to work out the most successful way to run trials to get the best evidence based treatment to as many as possible as quickly as possible.  On a more personal and perhaps selfish note, as a tax payer it’s my money which contributes to funding NIHR trials and my health which I hope will benefit!

Claire: Trials have an important role to play in health care, as Ailsa mentioned, yet many struggle to recruit on time, if they recruit at all and that’s before we consider the problems we face with retention. We hope a patient-centred approach will help us to deliver more effective trials. In time, that could mean exciting new approaches to engaging the public with the trials enterprise. This work also fits nicely with the NIHR core aim of creating a research active nation.

Why is it important to promote a research active nation?

Claire: We want to get to a place where it is normal for patients and the public to be invited to participate in research and to ask about taking part, to be involved in shaping the direction of research, to understand the purpose of research and its importance to our health care system.

Ailsa: Everyone has a personal interest in improving their own health and that of others close to them.  Healthier citizens mean a healthier economy!  If members of the public participate in research it makes the whole point of it more real for people.

International Clinical Trials Day, on May 20th, provides a great opportunity for us to reflect on our achievements in terms of developing new treatments, therapies and approaches to organising care but also to consider where we need to go next.

Why do you think there is a lack of research in this area?

Ailsa: A hangover of paternalism?  ‘of course patients are involved, we’re testing things on them’ and ‘but they aren’t researchers, so how on earth can they have anything to contribute?’  Researchers may also feel threatened that their scientific rigour is being challenged. However, one of the key roles of a PPI partner is to ask ‘why do you do it like that, rather than like this?’ to which the usual reply is often ‘because we always do it that way….’

Claire: In one sense you could say we have come a long way. Progress has been made in developing trials methodology, but as has been the case with research more generally, we have been far too slow to understand and capitalise on the expertise that patients bring to the table.

Where would you integrate patient-centeredness in a trial?

Ailsa: To be truly patient-centred it needs to be integrated from the very beginning– in fact, sometimes those very first thoughts on a research topic may actually come from a patient rather than a researcher.  The patient just needs someone to listen and take note.

Claire: I would turn that question on its head and ask where wouldn’t it be appropriate to integrate patient insights? Where in the research cycle wouldn’t it be appropriate to work in collaboration with patients? I think trials design can benefit from incorporating patient/ public insights at multiple stages in the research cycle.

I’ve been fascinated to see recent public crowd sourcing of research through sites like Walacea https://walacea.com/ . It’s the democratisation of research in action and shows there is an appetite for supporting research and getting involved.

what impact would you like your research to have?

Claire: I would like to see more patients, members of the public and community groups involved in shaping the design of trials. I would like to see trials recruiting to time and target and better equipped to respond as and when challenges arise- which they invariably do - and for patient experience to be captured routinely.  If this research contributes to those broader goals in some way – even if it helps us to understand what not to do as much as what to do, that would be great.

Where can people find out more?

Claire: We’re keen to hear people’s opinions on the topic so encourage anyone who is interested to look at our new website and to get in touch: http://www.populationhealth.manchester.ac.uk/patientcentredtrials/

For tweeters out there we use the #ImprovingTrials hashtag when discussing this topic and trials more generally.

@Claireplanner   @AilsaDon   @PatientTheme @NIHRSPCR



[1] Claire is funded through SPCR seedcorn funds & affiliated to the MRC North West Trials Hub