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The heart of the matter: Part One

Closing the clinical care gap
Over the last two decades the concept of evidence-based medicine, with its structured and objective decision-making process, has increasingly gained currency, as healthcare leaders, managers and practitioners look to ensure clinical practice keeps pace with the evolving base of medical evidence.

One of the pioneers of evidence-based medicine is Canadian doctor David Sackett, who in 1994 founded the University of Oxford’s Centre for Evidence-Based Medicine - the world’s first centre for evidence-based medicine. He described the concept as “the conscientious, explicit and judicious use of current best evidence in making decisions about the care of individual patients”. But making the best use of the best evidence is often not straightforward, especially in terms of its full implementation in real-life, everyday clinical practice.

Twenty years after the Centre for Evidence-Based Medicine was established uptake of evidence-based medicine still faces a significant barrier in the form of the ‘clinical care gap’. The well-documented, though as yet unresolved, discrepancy between clinical evidence and clinical practice is thought to be responsible for up to 40 per cent of patients not receiving care that is entirely in line with the current scientific evidence base. “The vagaries of human nature, information overload, time constraints, communication breakdown - these are just some of the reasons for the clinical care gap,” notes Charlie Buckwell, chief executive of McCann Complete Medical and Double Helix. “But whatever its cause, the gap is responsible for one of our key challenges - how to enable clients to combine insight, evidence and ethical engagement to support evidence-based practice.”

Pharma’s well-documented reputational challenges - particularly the perception of less than full data transparency - make addressing the clinical care gap a difficult road for companies to travel alone. Nevertheless, the industry remains well placed to offer an expert perspective on the role of its own products and now is not the time to shy away from engagement. As the continued existence of the clinical care gap proves, greater adoption of evidence-based medicine is still needed - but delivering it will require greater, not less, input from companies.

It’s a view that might resonate with AstraZeneca, a group of whose senior executives recently said “it is vital to ensure that teams are … recognised for the quality of their science, and are well connected to the external scientific community”.

The group, which included global head of innovative medicines and early development Menelas Pangalos, were outlining the framework that now guides AZ’s R&D teams. They term it the five ‘Rs’ and it encompasses the right target, the right patient, the right tissue, the right safety and the right commercial potential.

Writing in Nature Reviews Drug Discovery (June 2014, Vol 13, No 6) they noted the importance of aligning scientific opportunity with commercial insight and position. “We use the term ‘right commercial potential’ to describe confidence that a project would ultimately deliver a medically differentiated and commercially viable product,” they said. They go on to note that an evaluation of the factors behind the ‘right commercial potential’ requires “a clear dialogue between the commercial and scientific groups in the company that must always be underpinned by scientific understanding and medical need”.

Applying behavioural science
Connecting these themes will be critical for any company striving to close the clinical care gap. The starting point for addressing this must be to develop an insight-driven understanding of people’s motivations as a precursor to applying communication and engagement programmes to change the behaviours that cause the gap. Within a pharma framework the application of behavioural science moves beyond the traditional medical communications model of providing information and, to a degree, education, to target the attitudes, subjective norms and perceived behavioural controls with an intervention. This will first increase an individual’s intention to act and then in turn influence his actual behaviour.

The expansion of behavioural science within pharma has been assisted by a growing understanding of the common biases associated with the human condition. One of these is confirmation bias, an example of which might be dismissing evidence that does not support one’s own beliefs - something that can clearly work to widen the clinical care gap. Fabrice Allum, managing director of global market research at Double Helix, says it can be very hard for individuals to identify these kinds of in-built biases within their own actions. “We are very, very bad at interpreting our own behaviours, which is why it is much more powerful to observe behaviour within a framework rather than to ask someone to post-rationalise it.” These difficulties can be seen in physicians and how they understand and apply new science, or patients, and whether they take their treatment properly or feel able to make the lifestyle changes requested of them.

Researchers’ dedication to the science can also, albeit inadvertently, hold projects back. Allum explains. “People often have tunnel vision about the clinical aspects of the molecule they are developing and can lose sight of the needs of the patient.” He gives the example of work by his company comparing a monthly regimen to a weekly one - the monthly regimen was assumed to be more attractive to patients, given its less frequent dosing, but the different number of days in certain months actually meant that a seven day, weekly cycle was easier for patients, especially older people, to follow.

Finally, cultural context can be hugely important. Buckwell explains: “Attitudes vary widely to globally-derived data relative to local data or experience, indeed cultural influences on how data is perceived and utilised per se relative to more holistic or faith-driven perspectives vary widely across countries and regions.” A further layer of complexity can then be found in how different diseases are viewed, an area where Double Helix’s use of digital ethnography tools like video diaries has unearthed some really interesting findings. “Every disease area has its own specific context. It’s crucial to understand individuals’ perspectives on the daily challenges that affect their work life, family life, hobbies and so on,” Allum says.

If done correctly, such behaviour change can support better clinical and commercial outcomes. But it’s not a simple task, and requires innovation to be embedded within product design and development, along with a compelling evidence base that reflects the clinical, economic and real-world value needed, and detailed customer understanding. These in turn should directly drive communication strategy and tactics, so a ‘red-thread’ can clearly be seen back to the original intent.

Living in the real world
Out of all these requirements real world evidence, or what used to be more commonly known as non-interventional observational studies, can provide a very powerful way of exploring the evidence gap. In particular it allows new levels of clinical practice to be mapped and can be used to complement scientific understanding with real world decision-making as well as validating insights from a wide range of different stakeholders.

There is no doubt that randomised clinical trials (RCTs) are essential, explains Andy Turner, head of Complete True Life. “They’re essential to efficacy and safety from a regulatory perspective, but they don’t provide an understanding of how patients are managed in routine clinical practice,” he says. “Today’s environment is such that, from a health economic perspective, you have to be able to demonstrate the value of your products in true life populations.”

There is a growing appreciation of this within the industry, and companies are increasingly looking at coordinated programmes that combine RCTs and real world studies. These tailored programmes often cover areas such as database analysis and bespoke studies. If done well they could help regain the trust of healthcare professionals by providing a more complete picture of patient needs that will both resonate with them and expand their understanding of, and access to, high quality evidence.

But here the journey faces a potential roadblock - within a pharma company’s traditional organisational silos who takes responsibility for real-world evidence? “It’s poorly defined where it sits because it is, or should be, utilised by everybody. So it might fall within the remit of market access, epidemiology, health economics or medical affairs,” says Turner. “Real world evidence and insights are not aligned to one specific team and yet they’re the core of the brand, cutting across all functions.”

The need for a new approach to evidence was highlighted in Ernst & Young’s 2014 industry report, which found that the needs of payers and providers are not being met by pharma’s current practices and that, with healthcare budgets under pressure, stronger data is needed to justify a treatment’s cost. Proof of this can be seen in NICE’s recent reversal of its negative decision on the cancer drug Xtandi, where England’s health technology assessment (HTA) body was swayed by new observational data provided by Astellas. The decision is not a one-off. “More and more HTA bodies are going to insist upon evidence for a treatment’s real-world utility,” says Buckwell.

Showing RoA - return on activation
Once in place, and ideally work on addressing clinical care gaps would begin when a treatment is at phase I, real-world evidence can provide companies with the opportunity to ask harder questions of their activities, such as ‘what is the real-world evidence for the programmes associated with my product’. There’s no reason why real-world studies shouldn’t allow companies to investigate the real-world impact of an educational or adherence programme, for example.

This adds a whole new dimension to traditional questions of return-on-investment, offering the potential to measure return-on-education, return-on-evidence, return-on-treatment or return-on-activation. “A real-world study can show for one country or local area what happens with a programme and compare it to what happens in another country or area without that programme. It is a very exciting area and, in addition to helping people engage with the process, can actually demonstrate in evidence terms that different behaviours lead to different outcomes,” says Buckwell. “These types of studies are going to be very powerful. It’s a new, innovative concept, so clearly there has been some nervousness about whether can it work, but we believe it absolutely can.”

A fundamental consideration is how to design the right approach to developing evidence for a product, one that will be
compelling not in today’s market, but in 5-10 years’ time when that product is launched. Once a company has got that evidence, it needs to engage with different stakeholders in the most effective way to derive appropriate evidence-based usage and behaviour change. Real world evidence can be used to explore, design and deliver activation programmes that are integrated across time, tactics and stakeholders to provide clear understanding about the clinical care gaps in different cultures and therapy areas.

Despite the area’s complexity, a road map is emerging for pharma to follow on its journey to addressing the clinical care gap - though current industry practices can present some obstacles. “To address the gap you have to use a combination of connected activities which are repeated and include goal-setting and identifying ‘barriers to change’ in your communication and engagement programme,” Buckwell explains. “But this is where the industry faces enormous challenges, because right now its programmes are often disconnected. These disconnects might be between education and promotion, global and local, or between strategy and tactics, driven by many reasons at both an organisational and cultural level.”

So, while this is obviously a challenging time for the industry it is also the right moment for companies to step up and meet these challenges head on with integrated programmes to address the clinical care gap and deliver evidence of the value that their products and support services provide - the dominance of HTA will just not have it any other way. “Future outcomes, for both patients and industry, will depend on better alignment of clinical and commercial goals and a stronger definition of what constitutes clinical and commercial success,” concludes Buckwell.

Key Takeaways
  • What is the extent of the clinical care gap in your area of interest?
  • What is causing this clinical care gap?
  • How can behavioural change theory help address this gap?
  • How can real world evidence be used to explore the gap and measure the impact of your campaigns?
  • Have you ensured maximum efficiency gains by developing an integrated programme?

13th June 2014

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McCann Complete Medical

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