What does the Future Look Like for Patient Centricity within Clinical Trials?

Thought LeadersDr. Paresh MalhotraConsultant NeurologistImperial College Healthcare NHS Trust

In this interview, we speak to Dr. Paresh Malhotra about what the future holds for patient centricity within clinical trials, and the benefits for this focus.

Please could you introduce yourself and tell us what inspired your career into brain science?

Hi, I am an academic Neurologist based at Imperial College London-dividing my time between research clinical work centering on dementia and cognitive disorders. When I did my medical training, I was taught by some inspirational Neuroscientists such as Prof Colin Blakemore. I was also able to do an additional intercalated year and did a project in Neuropharmacology with Prof Trevor Sharp. This fascinated me and helped me make up my mind about the direction I wanted to pursue.

After qualifying as a doctor, I have been lucky enough to work alongside some brilliant clinical neuroscientists and they have been a continual source of inspiration and encouragement.

Clinical trials are extremely important to the scientific community but many trials still lack in putting patients at the center of them. Why is this?

When academic researchers start designing clinical trials, I think it is often possible to 'lose sight of the wood for the trees'. The immediate and most pressing focus becomes obtaining funding for a trial, then the next step is to maximize feasibility, and then to ensure adequate recruitment as well as trial completion on time.

The prize becomes a major paper or papers. And sometimes a nice result starts to be too focused on an outcome with a new and exciting biomarker. So this set of priorities starts to be foremost in researchers' minds when in reality, at the center of any trial has to be the patients who take part in the study itself and those patients who may receive a treatment based on the results in the future.

Clinical Trial

Image Credit: Den Rise/Shutterstock.com

How has patient-centricity changed within clinical trials over the last 10 years? Have you seen this becoming a more important focus for companies and researchers?

In academic medicine, at least, I think patient-centricity has undoubtedly become more of a focus in the design and implementation of trials. The NIHR (National Institute of Health Research) has really helped institute patient and public involvement as a key stage in clinical research in the UK. This is an explicit and important part of the grant application process, and researchers are actively encouraged to cost and plan for patient and public involvement. This was already the way some charities and funding bodies worked but it is now an integral part of the clinical research landscape and an essential consideration in setting up any study with patients, particularly clinical trials.

Since COVID hit, I think this has become even more important and not just because of the impact of COIVID-related research per se. The way we live and work has changed, such that many people work at home and travel a lot less.  Also, people can access medical data about themselves online and collect measures using smartwatches and other devices. Following on from all this, patients and their families expect a different approach to medical care and clinical trials.

Why do you believe it is important to put patients at the forefront of research? What are some of the benefits this has not only for the patients but the trial itself?

Patients and their families are best placed to really know what their problems are! Sometimes researchers are understandably excited by their own hypothesis or perhaps a particular new test or treatment that they might have devised, but these really don't matter in a trial if they have no relevance to patients' lives. If we engage with patients and their problems, we are far more likely to develop and test interventions that make a difference.

We are also more likely to recruit and engage patients so that they are more likely to stay in a trial. Crucially, they are also more likely to recommend participation to members of their personal networks. These are critical to any trial's success.

Another huge focus area people are turning to within the clinical trial space is inclusivity and diversity. Why is it important to have diversity within a trial and be able to accurately represent underserved populations?

Many of the findings in medical research that we think of as hard facts are in fact the results of studies carried out with extremely homogeneous groups that do not reflect the society in which we live. At the most basic level, this may consist of a major gender disparity. As someone who prescribes medications and recommends treatment for an extremely mixed and diverse population, I want to be sure that these therapies are appropriate for the whole of that population.

In addition, having the opportunity to take part in relevant research is an important part of receiving a diagnosis and being a patient in a healthcare system. Access to that research, particularly clinical therapeutic trials, should be available to the whole population and not limited by demographics, geography, or language. There is a long way to go before this is the case, but I think now that it is becoming a recognized problem, we can at least start taking the first steps. This is something that is being addressed by the NIHR and also needs to be considered by researchers when planning trials.

Diversity

Image Credit: fizkes/Shutterstock.com

The ongoing COVID-19 pandemic has taught us the importance of collaboration and how, by collaborating together, scientific and medical advancements can be achieved quickly. How important is collaboration within the clinical trial setting? Why is it important for there to be clear communication between patients and researchers?

As you might expect, I think collaboration is essential for any clinical trial. It is fundamental because successful trials genuinely require engagement from all team members with a diverse set of skills. At a broader level, the more that researchers from institutions across academia, industry, and the third sector can get together and collaborate, the more likely a trial is to be representative and of a large enough scale to make a difference to future practice. Involving patient representatives and advocacy groups at the earliest stages is essential. Ensuring that they have a voice on the Trial Steering Committee makes a big difference.

Clear communication between patients and researchers makes participation easier for the patient and enables researchers to collect appropriate outcome measures. In my own field of dementia and cognitive impairment, family members and carers are particularly important in the whole process, and their advice should always be listened to. They have provided us with invaluable advice about things like the tolerability of scans, the length of testing sessions, and the need for regular breaks.

In addition to formally requesting this input, I think it is of paramount importance that the patient-facing team tries to make a real connection with participating patients and their families.  That human touch can make all the difference to people who might be anxious about taking part in a trial.

What do you believe the future of patient centricity within clinical trials to look like?

I think patient-centricity will be as fundamental as ethical approval. Patient and carer input is already part of trial design and funding in many cases, and this will become the norm. At the level of the individual patient, researchers will try to make the process of participation as patient-centric as possible. Of course, it will not be possible to remove all hospital visits from all trials, but these will be minimized and remote monitoring and measures will be ubiquitous.

COVID has already enabled some of this, but I think the trend will continue. There is a lot of hype concerning wearables and some of it is justified, particularly with respect to monitoring things like oxygen saturations and obtaining remote ECGs. In neurology and dementia, I believe that there will be a move towards passive outcome measures where possible, allowing researchers to get as close as possible to measuring how an intervention changes a patient's life and activities. For instance, a passive measure of walking speed might tell quite a lot about a patient's mobility without the need for questionnaires and lengthy in-person assessments.

Since starting your career in neurology, what has been your proudest achievement?

I feel extremely proud every time one of my Ph.D. students is successful at their viva, and that I've really achieved something whenever we get the first patient enrolled in a new study. These moments are the culmination of several years' hard work and collaboration and it's a great privilege to be part of them.

Are there any exciting projects upcoming that you are involved in? If so, what are they?

We are now halfway through the NIHR NorAD trial, which I lead at Imperial. In this Phase 3 RCT, we are evaluating a repurposed medication that is normally used in ADHD for the treatment of cognition in Alzheimer's. It has been hard work, especially through COVID, but I'm very proud of the team that I work with for getting the project going and then keeping it running.

I also work with the UK DRI Care Research and Technology Centre at Imperial and the University of Surrey. Together we are trying to advance home monitoring and remote testing as much as possible, harnessing some of the amazing technological research that goes on at Imperial and potentially incorporating this into trials. This will make a real difference to how we monitor progression and measure treatment effects in dementia.

Where can readers find more information?

About Dr. Paresh Malhotra

Currently:

  • Reader in Cognitive & Behavioural Neurology, Imperial College London
  • Deputy Head, Division of Neurology, Imperial College LondonDr. Paresh Malhotra
  • Consultant Neurologist, Imperial College Healthcare NHS Trust
  • Divisional Director, Northwest London NIHR Clinical Research Network
  • Associate Member, UK Dementia Research Institute
  • Member, Alzheimer's Society Research Strategy Council
  • Member, NIHR Translational Research Collaboration in Dementia

Previous:

  • Fellowship of the Royal College of Physicians of London 2015
  • HEFCE Clinical Senior Lectureship 2011
  • Visiting Scholar University of Sydney 2010
  • Ph.D. University of London 2007
  • Qualified in Medicine from University of Oxford 1998

Research:

  • Commencing Phase 3 NIHR funded trial of Guanfacine in Alzheimer's (2019)
  • Showing clinical use of Amyloid PET scanning for diagnosis of Alzheimer's Disease in the NHS (2017)
  • Demonstrating that boosting motivation can improve attentional impairment after stroke (2012)
Emily Henderson

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Emily Henderson

During her time at AZoNetwork, Emily has interviewed over 300 leading experts in all areas of science and healthcare including the World Health Organization and the United Nations. She loves being at the forefront of exciting new research and sharing science stories with thought leaders all over the world.

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