The pharma industry is increasingly coming up against resistance as it struggles to fulfil the ever-increasing requirements of ‘wellness stakeholders’; a term referring to those individuals and organisations with a vested interest in the success and efficiency of the pharma lifecycle, from governments to payors to regulators to patients. The pressure is on for pharma companies, perhaps more than ever, to justify so many aspects of their products to these stakeholders. With cost-constraints tightening their stranglehold on R&D freedoms and changing demographics in the form of aging populations and rising chronic disease rates shifting the rules of the game, the industry is under pressure to evolve to keep pace with the demands of all of today’s wellness stakeholders.
According to the white paper Real-world evidence: A better life journey for pharmas, payers and patients: “Patients are looking for a better end result with their treatment. Providers are looking for data-oriented proof that the prescribed drug helps to optimise patient treatment, and brings added cost-efficiency and better profit margins. Payers (both government and private) are asking providers and manufacturers to prove and promote the benefits that they will reimburse for in their healthcare systems. Regulators, from the overall public health and well-being perspective, are also looking for evidence in a real-world environment.”
Expectations are high to deliver on these needs, and that calls for a solution that can meet the challenge, as Abhimanyu Verma, head of real world evidence and big data solutions at Novartis, points out:
“It is imperative that outcome-based and collaborative models be applied across healthcare systems to take a data and evidence-driven approach to ensure the optimal utilisation of healthcare resources to tackle the rising challenges and deliver the optimal patient outcomes. An approach is needed that brings together the different stakeholders – pharma companies, payors, regulators and governments working together collaboratively , rather than in siloed approaches , with the right joint incentives to deliver the common goal of positive outcomes for patients.”
All of these instances, defined by the requirements of modern healthcare, call for one thing: more evidence. The traditionally small-sample results presented by the tried-and-trusted clinical trial just won’t cut it. And that’s where real world data comes in.
According to the Association of the British Pharmaceutical Industry (ABPI), real world data is any data outside the controlled constraints of conventional randomised controlled trials to evaluate routine clinical practices – information harvested organically in the ‘real world’. This data is then assessed on its organisation, analysis and interpretation to generate real world evidence.
“It’s really any data that’s relevant which is derived from anywhere outside a controlled environment,” explains Andrew Roberts, director of market access and external affairs at Napp Pharmaceuticals. “It’s any data which could be relevant to the therapy area or the product that you’re looking to examine. I would define it as being that distinction as lacking a controlled environment such that you would find framed by a randomised controlled trial.”
So the nature of real world evidence is quite at odds with the data generated by the traditional clinical trial, as Roberts outlines:
“In a randomised controlled trial you’ll set quite distinct control boundaries that you’ll build into the design methodology of the study, and that’s always been purposeful to narrow the specific area that you’re looking to explore. Real world data is the complete opposite; it allows you to really explore all forms of data that may be relevant to the disease area. It allows you to assess how effective a medicine has been in a real world setting. So you’re not setting boundaries by definition because you want to see how a product might behave with patients that lead a particular lifestyle with a particular condition.”
Real world data is nothing new. The industry has dabbled in it for a short while, but it is for the most part still finding its feet with the methodology. But only now is the notion really starting to become an area of great promise.
“It’s a huge opportunity,” Roberts tells us. “It’s starting now and it is a relatively new area, but it’s developing very quickly. Real world evidence has been something the pharma industry has been using for some time; I’d say the last five years we’ve started to see real world data used very effectively, certainly in the UK, to discuss disease with healthcare professionals. The opportunity now is how that expands.”
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