Patient puzzle

Last month, I had the privilege of hosting a webinar for the National Institute for Health and Care Research (NIHR) on ‘Strategies for Growing Patient Recruitment and Retention through Inclusive Research Design and Delivery’ (watch via the QR code).

The discussion reaffirmed something that’s been increasingly clear to many of us working at the intersection of health research and healthcare: feasibility, as defined and practised by much of the life sciences industry to date, is evolving.

This realisation was further underlined for me while recently listening to Maya Zlatanova, CEO of TrialHub and FindMeCure, on Innovating Clinical Trials, the Podcast.

She highlights what she understands to be one of the sector’s blind spots – that feasibility is primarily assessed from the sponsor’s perspective: site capability; investigator experience; estimated participant numbers; anticipated costs-per-participant dominate the checklist.

However, the paradigm is shifting. Savvy sponsors now pause to ask a more fundamental question: is participating in this trial feasible for the patient? The NIHR is providing the mechanisms to help answer this question.

True feasibility begins with understanding the patient. That means assessing not just clinical eligibility, but patient motivation, treatment burden and access to care.

It means asking: How will they hear about the study? Can they attend when we are asking them to? Can they afford to outlay travel costs before being reimbursed? Will they choose to participate given the alternatives?

Ignoring it can be costly. Not accounting for the participants’ lived experience of participation may result in longer recruitment timelines, lower retention rates and exceeding study budgets.

On a micro level this might mean ensuring a participant, who is a wheelchair user, does not withdraw simply because navigating the fire doors on site is too difficult – this is a real example from our public contributor in the webinar.

On a macro level, we have to consider that all patients will inevitably compare trial participation to the care they’re already receiving. If participation is burdensome (e.g. demands frequent time off work) or offers little value (perhaps their current medication is working fine) from their perspective it may simply not be feasible to take part.

Participant motivation is key. As researchers we must balance the ‘ask’ of the research against the burden of living with the disease day-to-day. This is especially important for studies targeting more common, manageable conditions.

These studies must compete with the demands of everyday life and convenience will be a dealbreaker for many potential participants. Therefore, if your focus is fixed on getting to the milestone of first patient first visit (FPFV), without equal consideration of long-term participation, you’ve potentially introduced a risk into your study.

Assessing feasibility from the patients’ perspective requires investing a little more time and resources upfront. But this investment pays dividends as developing a deep understanding of patients’ constraints and motivations underpins reliable recruitment and better retention, (and can actually reduce the overall study timeline).

In my view, sponsors have two choices: you can plan and budget to fully understand the participant experience upfront and avoid withdrawals, or you can plan a bigger budget and longer timelines to over-recruit to offset withdrawals.

One of the common challenges, which can significantly impact the participant’s motivation and experience, is when a global protocol conflicts with local healthcare systems, standards of care, or patient access points.

These protocols can nearly always be tailored to better align with the patient pathway by changing the healthcare setting, adapting visit schedules, or using local terminology and languages more effectively. I see how these adjustments make participation easier, which supports recruitment and retention and helps to keep studies on track.

Taking a patient-centred approach also encourages global sponsors to consider our evolving healthcare systems anew for each study phase and sense check protocols and recruitment strategies.

The UK Government’s widely discussed plans to build an NHS that is ‘fit for the future’ includes a shift from ‘hospital to community.’ The need to reflect this broader trend is growing among global sponsors as they endeavour to deliver inclusive research closer to home.

Feasibility and site selection processes also need to mirror these changes by asking the right questions at the right time to create an accurate blueprint for study delivery. If not, the disconnect between sponsor expectations and patient realities creates unnecessary friction.

Sponsors now routinely review protocols and participant information from a patient perspective. We can go further by reviewing our processes in the same way. The aforementioned webinar highlights strategies and support available from the NIHR to do this, across the study life cycle.

Before research begins, clinical and care experts from across the UK can be engaged through the NIHR to help align protocols with local patient pathways and standards of care. Similarly, the Patient Engagement in Clinical Development (PECD) service, helps companies embed the patient perspective early, ensuring trial schedules and activities are acceptable and information is accessible.

After design comes delivery. The NIHR’s ‘right research, right setting’ standpoint is the driving force behind its Agile Research Delivery support. This peripatetic research delivery workforce encompasses roles tailored to delivering research in a range of settings where patients receive their care – including primary and community care.

When trials conclude, the Participant in Research Experience Survey (PRES) is helping sponsors learn directly from the people who matter most: participants. Some companies now deploy PRES at predefined points, such as at the last patient visit.  Feedback is translated into insights to shape the next trial phase and future trial designs, helping shrewd sponsors to iterate on what works and build organisational learning.

As we heard in the webinar, we’re already seeing sponsors create their own internal playbooks – based on insight garnered from NIHR services – to drive better study design across whole portfolios of research.

We know recruitment and retention are two of the biggest barriers to success. If we want to change this, we need to do things differently. But too often, we are wired to focus more on protocol fidelity and milestone metrics, and invest less in understanding the participant’s perspective. So, what needs to happen?

Reality check. Start with patient realities not site logistics.
Design trials with people (not procedures and processes) front of mind.
Convenience is key. Look beyond hospitals towards primary care, community and residential settings.

Collaborate and learn. Share what works and build confidence in new ways of working.

Professor Margaret Ikpoh is National Specialty Lead for primary care at the National Institute for Health and Care Research (NIHR)