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Personal Development

EPC: You started out as a registered general nurse (RGN). How did you become interested in patient recruitment and engagement specifically?

Judith Teall: Throughout my career, I have always had a keen interest in healthcare and patients. As a nurse, the delivery of healthcare to patients is your primary focus. You are surrounded by individuality and new challenges every day. There is an enormous human factor to the role, and you can become very connected with the patients – really getting to understand not only the physiology, but also how the disease or condition is affecting their daily lives. This forms part of the care plan, and in the hospital setting, the patient’s progress is measured against this. Each care plan is tailored to that individual in order to get the best results from their treatment.

As I was just qualifying as an RGN in the late 1980s, an evidence-based approach was just starting to embed itself as a standard component in the training. It seemed obvious that this was the way to go. For me, based on a natural thirst for finding the best way of doing things rather than just blindly following the same routines, this led to a new career path in pharmaceutical clinical research.

After 17 years in both therapeutic and functional leadership roles in the industry, all points seemed to converge on patient recruitment and engagement; it had always been the singular biggest challenge in clinical research and offered an interesting opportunity to blend both my nursing and industry experience, as well as bringing in my creative slant. With my frontline understanding of what patients were going through in managing their day-to-day lives, it was a natural step to create a focus on patient profiling, from which teams could begin to plan patient enrolment and engagement strategies.

Where did your interest in patient-centricity derive from?

I came into clinical research through a very patient-centric route – nursing – so I have always been a huge proponent of putting the patient at the centre of everything. In addition, as the mother of a 20-year-old son with a disability, I have also seen long-term multidisciplinary healthcare close up through the eyes of a caregiver. When moving from one hospital visit to another, it always struck me that there must be a better way to link the treatment management, often finding that I was the lynchpin that held it all together.

As I was fortunate enough to work in healthcare, I could understand much of what was being proposed or asked of me, but I was aware that most people would not be in that position. It would have been invaluable to have had the tools and technologies of today’s mHealth world at my disposal back then, so that I could track my son’s progress, understand key regimes to follow, and carry a care plan with me to all appointments to share with other healthcare professionals (HCPs). This would have been so much more straightforward, and would have given my son the opportunity to manage his own condition as he transitioned into independent living.

How has your role changed over the years, and what are the most important innovations in the healthcare industry that you have worked on?

My roles have offered me an enviable 360-degree view of patients and healthcare. As a nurse, I saw the HCP perspective, delivering at the ‘coalface’, and then as a clinical researcher I saw the industry angle – with much more of an appreciation of the scientific, business and economic realities. From my current role within a vendor, I have a great vision across multiple stakeholders, and can see how different groups are tackling the issues. And behind the scenes, I continue to wear the carer hat.

So for me, it has not only been a personal growth, but also the witnessing of an evolution within the healthcare industry. We are clearly under tremendous economic pressures, both now and for the foreseeable future, and it is a given fact that the path we are on with the current healthcare model is just not sustainable.

Personal computing and the internet has revolutionised most industries beyond recognition; I remember seeing a computer for the first time while nursing in the NHS – only the ward clerk was trained in how to use this unknown quantity, and it was huge. In clinical research, I recall writing protocols and printing out multiple hard copies to courier over to the US team for review. As you can imagine, the end-to-end process took a long time.

Now here we are, with personal technologies accessible to everyone, for everything, in smaller and more user-friendly shapes and sizes than we would ever have believed possible. Communication has speeded up massively, and our hunger for healthcare information – and our ability to reach it – has increased too.

So, in answer to the question, I would have to say the internet. It has changed not only the way in which healthcare is delivered, but is also enabling the next generation of patients to become more informed and active participants in health management.

Why do clinical trials fail, in your experience?

There are many reasons, some of which are very specific to the compound itself, such as unexpected safety issues or inconclusive effi cacy. However, on the whole, clinical trials tend to fail for the more non-scientific reasons, such as difficult-to-recruit study designs and poor planning. The inability to recruit a particular patient population is still cited as a frequent reason for delays and failure, and just like any other part of study planning, requires significant attention. In today’s highly competitive market environment, a delay could spell the end of a compound’s chances, as often there is simply not enough bandwidth to support being a late-comer onto the market.

Given that patients are often so hard to find and bring into studies, they should be treated like royalty once they are recruited, in order to optimise their trial experience and minimise the ‘avoidable’ discontinuations through drop-outs and patients who become lost-tofollow- up. Patient engagement is simply common sense, but sadly it has taken the industry a long time to get to the point where it is being truly recognised by all stakeholders.

Furthermore, clinical research is still highly inaccessible, as it is not sufficiently well known within the general public at large. The advent of the internet, social media and new technologies is helping to turn this around, with much broader advertising campaigns being made available, as well as more intelligent channelling of communications to relevant individuals.

How can sponsors ensure that Phase 2 to 4 clinical trials remain cost-effective but also engaging for patients?

I believe that planning for success starts with successful planning. So, in order for sponsor organisations to maximise the potential for costefficiencies as well as a good patient experience, it is advisable for them to consider both the high-level strategic and also the lower-level tactical patient engagement plans that can achieve their objectives. Many times the sponsor can leverage costs by planning across a programme, rather than just for individual studies – the principles and messages are often largely the same and can easily be implemented widely, even if it requires slightly differential messaging, such as for sub-populations or sub-studies.

The patient-centric approach means that site-patient communication planning should start with a full understanding of the patient profile; this drives the way in which messages can be designed and delivered for greatest impact. After all, the more the patient population can be understood, the more likely it is that the study will not fail due to discontinuations. However, if this step is condensed too much, or not executed at all, the impact is reduced.

All too often, patient engagement is the last thing that is considered in set-up, and often it is too late. Patients have a choice to be part of a clinical trial, and with today’s complex study design and the burden often being passed onto the patient, it is not always made easy for them to succeed and stay the course. There is often a very fragile balance – clinical trials rely totally on the goodwill of patients, so if they do not feel supported or valued in their experience, they will disengage.

The return on investment from putting a robust patient engagement plan in place can potentially be gained through a number of avenues: by reducing the recruitment target by taking out the insurance policy ‘padding’ that is added to the sample size specifically to cover discontinuations – typically an extra 10 per cent; by reducing missing data and hence increasing quality; by reducing the need for replacement patients; or, in large events-driven outcomes trials, by retaining the maximum pool of patients in which to see events, thereby bringing the trial to an earlier close and reducing the duration.

What do your foresee as the next round of mobile innovation and how will it help in engaging patients to capture data?

As an industry, we have to be very conscious of the ageing population. Globally, the over-60 demographic age group is simply exploding. In 1980, there were less than 400 million over-60s; that had more than doubled by 2010, and by 2050 it is expected to top two billion. Therefore, I believe that future mobile innovations will be geared towards addressing the varying challenges of the elderly population – a group which brings with it the need for concomitant condition management, as well as varying levels of sensory degradation such as hearing loss, arthritis and visual problems.

This increased accessibility will become an important factor for the data capture needs of the future. Whether as an integrated part of a clinical trial, or as a mainstay in managing their healthcare through mHealth, the increasingly demanding and aware 21st century patient will be looking for greater support through mobile technology. After all, we manage our finances, education and social lives on the mobile platform, so why not come to expect support in healthcare to be made available as standard too?

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Judith Teall is the Director of Clinical Excellence at Exco InTouch. She originally graduated as a registered general nurse before gaining 20 years of experience in clinical research from major pharmaceuticals, culminating in a patient recruitment and engagement focus. Judith brings this multifaceted background into her keen interest in patient-centric clinical research approaches.
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