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The balancing act: How patient engagement can improve recruitment and retention

Published: 22 May 2019

Balancing the ‘ask’ of research with the burden of disease is essential to achieve good recruitment and retention in clinical research studies. Dr William van’t Hoff explains how the NIHR is connecting life science companies with patients who are helping to get it right first time.

As a paediatrician and a researcher I really see, and experience, the challenge of conducting clinical trials with children. There are many factors which influence the family’s decision whether or not to take part, but I would say that first and foremost we need to ensure that the ‘ask’ of the research is balanced with the burden of the disease.

For example, for a life limiting disease like cancer you might expect a trial to be quite intensive in terms of treatment sessions, hospital visits and tests. But that same regime would be less acceptable for a long term condition like asthma, which many people manage with medicine, at home, on a daily basis. If we have a mismatch, in other words if the ask of the research is heavy where the burden of the disease is light, patients are less likely to participate and it will have a significant impact on a study, from approvals right through set-up and recruitment.

So how do we prevent a mismatch from happening?

Patients are experts in their conditions and they are the only people who can truly tell us if we are achieving the right balance between the ‘ask’ of the research and the burden of the disease.

Seems like a very straightforward solution doesn’t it?  Indeed, meaningful patient engagement and involvement activities have been taking place across the NIHR for over a decade, but more so in non-commercial research (funded by government, universities, research charities) than in commercial research (funded by the life sciences Industry). 

Time for change

If we want to do commercial clinical research better, and more effectively, this needs to change.  

However, we recognise that there are tensions in this area. Some members of the public are unclear about  what drives the life science industry and how they operate. Meanwhile some of the life science industry codes of practice and regulations - which are entirely appropriate - may seem like an impediment to the way that they engage directly with patients and the public. It’s crucial that we overcome these challenges and find a way to bring patients and the life sciences together to achieve the balance described above...

...And that’s exactly what the new NIHR Patient Engagement in Clinical Development service is doing. 

Bringing patients and life sciences together

The aim of the NIHR Patient Engagement in Clinical Development service is to involve patients right at the beginning of the clinical development process, at the protocol development stage, to help improve the design and delivery of commercial clinical research.  The NIHR is in a unique position to be able to broker this relationship as a neutral, non-profit organisation, embedded in the NHS, with a long history and track record of supporting the life science industry to deliver clinical research in the NHS.

For me personally, this work also builds on over 10 years experience of involving patients with funders of research. From that experience there are some key points - which apply not just to children, but to all ages and specialties - that I’d like to share with companies that are considering using the service:  

  • Invest time up front
    Firstly, this is new and difficult for many life science companies, so expect it to take a little time to get everything in place to enable meaningful engagement to happen. Companies should get in touch as early as possible and talk to us about the possibilities and the process. It’s important that you plan well and are very clear about what you wish to ask, or have patients comment on. This will enable our team in the NIHR to prepare and, by allowing a little extra time at the beginning of the clinical development process, you can expect that investment to pay dividends overall in the drug or treatment development programme.

  • Expect the unexpected
    Secondly, be prepared for the unexpected - if you know the answers why are you asking? Both patients and companies are going to hear new perspectives and sometimes, they may be challenging. But you should consider the added value of these views and opinions to your drug development programme. That will be noted in your ethics submission and will be abundantly clear in your patient  information leaflets.

  • Get fit for the future
    Thirdly, involving patients and public in drug development shouldn’t be just about clinical trials. I think the way society is evolving (in terms of populism, science, technology and, importantly, transparency) is really relevant to health research. So I believe that there are roles for patients from early drug translation right through to post authorisation and real-life experience. I see and hear of many patients who are keen to contribute at all these different stages. Building an open, transparent and publicly acceptable relationship with patients is going to enable us as health researchers, and pharma companies as innovators, to evolve our research processes into models that are fit for the 21st century, and for the people we are working for.

Watch a video of Dr van’t Hoff explaining how a new NIHR service is bringing patients and the life sciences together to help achieve a balance between the ‘ask’ of research with the burden of disease.

Find out more about the NIHR Patient Engagement in Clinical Development Service.

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