You’ve Got to Mean It

Patient involvement in research is increasing but pharma needs to get serious to create genuinely meaningful relationships.

After a life-changing diagnosis of throat cancer in 1995, former teacher Derek Stewart became involved in patient advocacy, focusing on ensuring the patient voice is heard in research.

“Some people get on a bike or climb mountains, others donate clothes to charity shops. Many patients voluntarily consent to take part in research in the hope that others don’t have to go through what we have gone through. Having been a participant in research myself, I know how important a patient’s perspective can be in improving the quality of the research, especially in the design stage. This is why I’m so actively involved in working collaboratively with the research community,” he says.

One day a week, Stewart works with clinical research networks as part of his role as Associate Director of Patient and Public Involvement & Engagement at UK’s National Institute for Health Research (NIHR), a government body funded by the Department of Health.

“The UK leads the world in terms of patient involvement in research but that doesn’t mean we always get it right,” he says. “We have a rich history. For more than 20 years, INVOLVE has brought together expertise, insight and experience, and offered advice on how to effectively involve the public. Policy in the UK is moving towards being citizen-driven; we have increasing numbers of patients working alongside researchers through the entire research cycle, even as co-applicants, and we have patients sitting on funding bodies and helping to drive policy. Their voices are being increasingly heard.”

Many stakeholders are involved in shaping this involvement, he says. “Although INVOLVE is an important body, researchers need more focused and contextually based advice, so several patient organizations have been looking to offer more specific advice to researchers.” Earlier this year, Parkinson’s UK published Patient and Public Involvement: A Resource for Researchers, offering advice on how to involve people affected by the disease at all stages of research, while Cancer Research UK is increasing patient involvement in research and organizational development.

Meaningful involvement

A motivating factor behind these publications and Stewart’s own efforts is the need to make patient involvement in research as meaningful as possible. He says: “Consultation and collaboration are often good starting points, but consultation can masquerade as involvement. ‘Meaningful’ starts with a cup of tea and a biscuit, people coming together for a meeting. Meaningful is when someone is prepared to reimburse a patient’s travel expenses to attend that meeting. Meaningful means holding that meeting in a non-clinical setting so patients feel more relaxed. Meaningful means involving patients early on, ideally at the start when the research team is just thinking about developing a new drug or device. Meaningful is the acknowledgment of the value of the involvement and the reciprocal nature of how we learn from each other. Feedback from patients is one thing, but a genuine relationship is another. It takes time to build up a strong, two-way relationship.”

I am hearing words from senior execs in pharma companies that I have never heard before about the need to engage and involve patients.

A key element of a meaningful engagement is to make sure it is context-specific, he says. “When I was a teacher, I would attend training courses and I would sit there thinking, ‘this doesn’t apply my job with challenging pupils’. However, when someone came into the special unit with the same ideas I was able to see how I could apply it. Knowing how to make the most of patient involvement is the same – INVOLVE gives sound general advice and charities are now beginning to offer more specific advice on how to work with their patient populations.”

He sees a role for pharma companies too. “Pharma could play a part here; companies could produce advice on how researchers or patient organizations can work ethically with pharma or how researchers can work with patients in the clinical setting. Those working in a lab or on a medical device may need a very different kind of patient involvement than those trialing a drug in a clinical setting.”

Pharma could also get involved strategically. “If pharma companies were able to provide some pump-priming money, a few thousand pounds, or maybe coordinate their efforts so that Company A develops guidelines and Company B develops support materials for researchers, then you could really change the landscape.”

Stewart is encouraged by the efforts made by many companies to involve patients in a meaningful way but there is still work to do, he says. “I am hearing words from senior execs in pharma companies that I have never heard before about the need to engage and involve patients. I am also hearing from a few people who work with industry at a more local level that they haven’t quite caught up with the organizational and cultural shift. There is a danger that they’re just going to a small number of patients with a few questions rather than engaging in an authentic manner.”

Diversity challenge

With patient involvement in research deepening and evolving, there are several challenges that Stewart is keen to highlight. The first is diversity. “Too often, it seems that researchers have gone for the low-hanging fruit when it comes to recruiting people into trials. It’s relatively easy to engage and actively involve mainly white and educated segments of the population. This is neither representative of our rich cultural diversity nor does it provide us with the quality of evidence required. My passion is how to reach out to those communities and to listen to those seldom-heard voices.”

He mentions East London Genes for Health, an organization aimed to improve the health of South Asian people in London. “I hear researchers saying they cannot reach certain populations but this group aims to recruit 100,000 Bangladeshi and Pakistani women. They have already recruited 20,000, in what can be perceived as a difficult-to reach group; they are demonstrating that it can be done. They want to work with industry and there are many other patient groups and organizations that want to do the same.”

Another issue Stewart is concerned about is the rise of the expert patient advocate. “Our mistake – and it could be pharma’s too – is that you engage with informed patients, people who are not researchers nor in pharma but they are not really average patients either. They become neither fish nor fowl, and are easy to engage because we understand the basics of patient involvement. The danger is that we culturally assimilate with the research community and with industry. We have to make sure that we involve today’s patient who is going through a range of real experiences right now.”

He points to AstraZeneca’s approach as best practice. “AZ does this well – it goes out to one group of patients when they have an idea for a drug, and they ask what they think, but when they develop a study, they bring in different patients, an entirely different group. After that, when they want to test recruitment ideas, they might go to a hospital or to potential participants and they ask them. Models that segment patients in terms of their roles and experience demonstrate the best practice of gathering a range of opinion.”

Stewart ends by calling for greater coordination of effort. “It was great to see the ABPI and AMRC holding a Patients First meeting recently. I have since been asked to speak at a working group looking at how we work better with industry. I think this is essential because what we are seeing is a lot of separate conversations - industry is talking about it, charities too as well as the research community. I want to make sure there is a thread running through it so everyone knows what’s going on. We’re all too busy to duplicate and worry about who is doing what.” 


Extracted from Trends in Patient-Led Clinical Trials magazine. Click here to download.

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