From participants to partners: The evolution of active patient inclusion in trials

Recruitment numbers are the backbone of clinical research. Without correct recruitment numbers, study results can be invalid, preventing new treatments from becoming available for patients and creating unnecessary additional costs for organisations. Plus, research may not be generalised to practice if the population is not diverse and representative.

However, achieving recruitment targets is just one part of the puzzle; retaining participants poses its own set of challenges.

Here, Professor Melanie Davies – clinical director at the National Institute for Health Research (NIHR) Patient Recruitment Centre, Leicester – sheds light on the evolving role of patients and how engaging with individuals before and during their healthcare pathway can lead to successful recruitment and retention to clinical trials.

Embed research into the community

At an organisational level, establishing a patient community that is research-aware and research-active is essential. The aim is to develop local communities where hospitals, GPs, and other healthcare-providing sites are viewed as trusted sources for information on research, the benefits of research are known widely around the community, and that people know how to access these systems.

To achieve this goal, community leaders need to be engaged in research. These influential individuals can play a pivotal role, sharing relatable stories that can help to normalise the perception of research in the wider community. In the past, there has been a lack of this kind of research role model, and it is still an area that needs further work.

The power of this community-driven approach was illustrated during the Ensemble 2 COVID vaccine trial. One of our first recruits was a community leader and we were able to promote his involvement in the trial via radio, through interviews, and cascade this via word of mouth to engage hard-to-reach communities. This engagement acted as a catalyst, enabling the recruitment of 700 patients in six weeks.

For research sites, it is important to have links to the community that are not related to a specific study. For example, attending events such as a dance group, where you can go along and talk about research, but you have to get up, join in, and have a dance. In doing so, we are bringing research into an environment that is comfortable for the community, rather than the other way around.

It is becoming increasingly important to work in this way, developing a wide network of different opportunities to engage with a broad range of people to match the varying recruitment needs of different studies.

For example, we have worked closely with the Centre for Ethnic Health Research since its inception to involve and understand the needs of ethnic minority and underserved communities when planning and undertaking research.

Communication is key

The principles of communication are the same across all aspects of healthcare, being respectful to patients, communicating clearly, and valuing their time. However, these core values can sometimes be unintentionally overlooked.

Researchers can use a variety of methods to engage the patient more effectively, including:

Translating information sheets into a variety of languages
Increasing the use of easy to access platforms, such as social media
Using simple, easy-to-understand language to communicate with potential participants

Building an understanding of engagement considerations among the staff members involved in research can also help. For example, through training, such as the cultural competency training we conduct at PRC: Leicester.

Alongside using a variety of methods to engage patients and participants, it is essential to continue a dialogue with them throughout the trial. One small, but highly impactful, act is simply to thank people for their time taking part in a trial. Participation in a study can last three or four years of their life, so, it is important to always acknowledge that commitment. Moreover, inform them when the dissemination of results will take place in a way that is accessible to many and relay a summary of the results to them via informal methods, such as a coffee morning with the research team.

The use of NIHR Participant in Research Experience Survey (PRES) is another communication tool at our disposal. This allows us to collect feedback from the participants in real time during a study, which we can then put into practice.

Use of technology

The rapid development of technology in recent years has provided more mechanisms for communicating with patients and participants than ever before. Digital pathways can be used to increase participant recruitment by reducing the need for face-to-face appointments.

Social media and websites are a tool that can be easily and quickly updated. Content should be directed towards the participant, ensuring they feel research-ready. For instance, on our website you can find videos such as ‘What it’s like to be in the PRC?’ and ‘What it’s like to take part in a trial?’.

You can also use data to understand what your organisation needs to improve upon. One way of doing this is by looking across services and analysing information to gain insights. Perhaps you will spot trends suggesting that DNA rates in clinic were higher in some ethnic populations, or related to childcare or language barriers.

Develop relationships with primary care

Primary care sites have a unique connection to local communities, which makes them a promising option for delivering clinical trials.

The datasets in primary care are excellent and there is a trusted relationship with the GP and patient. Researchers can use primary care as an avenue to help identify participants and to conduct the study. In fact, we collaborate closely with primary care providers when delivering commercial trials, often using a Participant Identification Centres (PICs) model. Some studies can be very complex and require specialist delivery, so this model allows sites to refer potential participants to us to conduct the research at our site – thereby reducing the workload for primary care.

Nurture your relationships with primary care providers, even if it is just a study poster in their waiting room. It’s another outlet and opportunity to engage patients.

Patient engagement is not one single thing, it requires an organisational approach. Everybody has a role in being an advocate for research. Every patient in the NHS should have access to research, we should not drive worse inequalities by only using the tried and trusted methods in recruitment. Significant investment in this space and a continual improvement methodology needs to be employed as communities, communication, and our understanding change.

Professor Melanie Davies CBE, MB ChB, MD, FRCP, FRCGP, FMedSci

Melanie Davies is professor of Diabetes Medicine at the University of Leicester and an honorary consultant diabetologist at the University Hospitals of Leicester NHS Trust. She is the co-director of the Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust.

Professor Davies’ research interests include the causes, screening, prevention, self-management, and treatment of type 2 diabetes mellitus. She is a National Institute for Health Research Senior Investigator Emeritus and Director of the NIHR Leicester Biomedical Research Centre and co-chair of EASD/ADA’s Consensus Report on T2DM Management.

Professor Davies has published over 800 original articles and has over £100m of grant funding. She was awarded the CBE (Commander of the Most Excellent Order of the British Empire) in the 2016 New Year’s Honour’s List for services to diabetes research.

The National Institute for Health Research (NIHR) is the nation’s largest funder of health and care research. The NIHR:

Funds, supports and delivers high quality research that benefits the NHS, public health and social care
Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR supports applied health research for the direct and primary benefit of people in low- and middle-income countries, using UK aid from the UK Government.

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