Learning from patients to make research participation less of a trial

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By Michele Teufel, Patient Insights and Solutions Lead, Development Operations, R&D, AstraZeneca

For great science to get from the lab to the clinic, research is essential. However, just 3% of patients ever take part in a clinical trial. There are numerous reasons for this, but they include lack of awareness, lack of understanding of what trials aim to achieve and the burden trials put on the lives of people taking part. It is clear that more needs to be done. 

At AstraZeneca, we are constantly listening and learning from patients and harnessing the science of behaviour change with the aim of transforming what it means to be involved in a clinical trial. Practically, this means using digital tools, empowering patients and removing obstacles to taking part. We know that the best science doesn’t happen in isolation so in addition to internal capability builds, we collaborate with experts around the world to help us address these challenges.  

For this article, I spoke with Professor Isla Mackenzie, a leading specialist in remote trials from the University of Dundee, UK; Professor Rob Horne, a behavioural science expert at UCL, UK; and Matt Bonam, who heads the AstraZeneca BioPharmaceuticals R&D Digital Patient Health and Innovation team, to discuss how what patients tell us is helping redefine clinical trials and offering a more positive and inclusive experience for patients.

Michele Teufel (MT): One key thing patients say to me and my team is that the offer of a trial gives them hope. How much do you recognise that sentiment from your work, and what other reasons do people participate in trials?

Isla Mackenzie (IM): The reasons patients choose to get involved in trials are multi-faceted, but hope is right up there. Many patients grab the chance of more focused care that’s available. But what’s also interesting is that a lot of patients take part for completely altruistic reasons, to help others. I guess that’s offering other people hope.

Rob Horne (RH): Clinical trials participation is influenced by an individual’s motivations and ability to take part. There are many reasons why someone might not take part in a clinical trial or drop out early but they can can be summarised as ‘can’t’ or ‘don’t want to’. Motivation is fundamental. To improve patient engagement and experience of trials, we need to understand the perceptions (beliefs, feelings and experiences) that influence their motivation to start and continue (or conversely to decline or discontinue). When we hear patients say that trials give them hope, that’s something we need to harness.

MT: The word we all too often hear from patients taking part in trials is that they find themselves ‘grappling’ with the impact it can have on them and their family. What are the current implications of clinical trials on patients and what can we do about them? 

Matt Bonam (MB): Burden plays a big part. Regular monitoring is essential, but we acknowledge the burden it can have on patients’ lives and it is something we’re constantly looking to address. For example, in one trial, as well as going to the clinic to get the treatment, a blood test every two weeks is needed which means patients would need to go to hospital for an hour and a half every two weeks for 52 weeks. That is a considerable burden so we’re working with the team to identify at-home tests that collect the same data. We’re aiming to reduce the number of hospital visits patients have from 26 to four across the study. This also means that, by collecting much of the data we need at home, the face-to-face visits patients do have with their clinician can be focused on them rather than the collection of data.

IM: Practical difficulties like parking at a busy hospital site often get raised by patients who are participating in a trial. For any trial, we need to make sure it is manageable and understandable, feasible and practical. And that's why having patients involved in the planning of a trial is really important.

MT: Ultimately, we need to find a balance between the science and the burden. Before trials even start, we are now building assessments of the patient impact upfront, so we know what’s being asked of them. How we ask is as important as what. Patients often report difficulties with documents such as informed consent forms. How should we be improving patient information to make the trial experience better for patients?

IM: At Dundee we’ve been running remote trials for over a decade and we’ve learnt that valuing the patient is extremely important. People want to feel valued, appreciated, that the time they’ve given up is contributing to a valuable research question and they want to feel that they're making an important contribution to science and medical research. That means setting out to answer a question which is valuable both to medicine and the patient and maintaining ongoing communication during the study period.

MB: At AstraZeneca one question we ask about all our trials is: What do we need to do differently to make it possible for an individual to take part in the trial? Out of necessity, a lot of legal information must be included, but we increasingly know this can be difficult for patients to understand. For example, the informed consent process has to date been lengthy, highly scientific, complex and paper-based. We’re now creating content in a multimedia format that is more easily digested and understood. By making the information easier to absorb we empower all our patients to make truly informed decisions and maximise their clinical trial experience.  

RH: Empowering decision-making is at the heart of a pretty unique collaboration we’re running with AstraZeneca R&D. Our aim is to blend behavioural science insights and digital health tools to create an app that identifies potential participants according to the perceptions and practicalities influencing their motivation and ability to participate. This will allow us to provide information and support tailored to their specific needs, which will empower them to make a truly informed choice.

MT: Patients often tell me they want to see digital technology better utilised when we design studies. How are these innovations helping us transform clinical trials for the better? 

MB: In the Digital Health R&D team, we want to redefine clinical trials and part of our strategy is focused on how digital, data and analytics can improve patient experience in trials and, more importantly, the overall outcome for those patients. In a review we conducted of over 90 protocols, we found that up to 70% of trial data could be collected remotely. Across our therapy areas we are implementing strategies that aim for the majority of our clinical trials to be hybrid, with most of the data being collected from home utilising devices and apps to support patients.

IM: Trials are microcosms of everyday life. We all use devices like mobile phones and many use activity trackers. Most people are comfortable with these devices, so are happy to use them in a trial, with the appropriate education on anything that’s unique, which should be created in partnership with patients.

MB: One paediatric asthma study we’ve run would have historically seen children going into clinic for an entire day for multiple days over a short period. That has a huge impact for them - missing school, not being able to play with their friends - and their families. But using a mix of technology and home nursing solutions at their house, the patients were able to remain at home for the vast majority of that study. This had a positive impact on those patients while still helping us to deliver our research.

MT: What might the trials of tomorrow look like, and how might the role of digital technology evolve?

IM: In the next few years, I believe the majority of trials will include remote elements. Everything is moving that way and this pandemic is merely accelerating the trend.

MB: These so-called ‘hybrid’ trials take the best elements of patient care: giving people the face-to-face clinical care which we know is so important, while reducing the need to travel and wait for routine testing and monitoring. Technology is the key to enabling this. Once you are able to interact with and collect data from patients from home more regularly, you have the potential to also help them better manage their disease and connect them more closely to their healthcare teams. Combined, it is hoped these factors will contribute to improving their overall health outcomes.

RH: Everything we do must be about understanding and addressing people’s perceptions of trials to support a positive engagement and experience, so that taking part becomes more the norm, which would be hugely important for the development of new ways to help patients.

MT: I think that’s a great sentiment to end on. The future of trials is one of normalisation. By making trials a more positive experience, I hope they will be increasingly part of everyday life. None of that is possible without true partnership with patients.