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Thought leadership and innovation for the Pharmaceutical Industry

Louise Kelly speaks to Dr. John Parkinson, Director of the Clinical Practice Research Datalink about Real World Data, it's true value in improving the clinical development process and its ability to drive costs down.

By Louise Kelly on Feb 21, 2013

Using the right type of data in the correct manner within the pharma industry fosters the healthcare of patients and assists pharmaceutical companies to demonstrate the value of their products to the necessary regulatory bodies. But it is the effective and efficient gathering of this real world data (RWD) at the right time – and in the right place – that will really help bridge the gap between the development of medicines and what happens in real life clinical practice.

The healthcare landscape is constantly evolving and adopting new medicines into the marketplace. It is therefore expecting the same innovative response from the research quarter, looking to move on from randomised controlled trials (RCTs) to more sophisticated evidence-based criteria – in such a way that facilitates positive collaboration between the pharmaceutical industry, academic researchers and clinicians.

Demonstrating true value

In the early stages of the drug development pipeline, there is always a drive to gain more access to reliable information.  Armed with this knowledge, pharma researchers and manufacturers can then work towards producing a new, improved product or treatment that will benefit the health of the patient and be transparent in its worth, according to Dr. John Parkinson, Director, Clinical Practice Research Datalink (CPRD). “If you understand the current way a treatment for a particular disease takes place and the inefficiencies in that process or the lack of desired outcomes that are reached, you are then available to better focus your research.”

“It enables you to build up a better picture of the cost of current care and the potential for what the added value of the product may be worth.”

“Furthermore, it enables you to build up a better picture of the cost of current care and the potential for what the added value of the product may be worth, with different and perhaps better outcomes,” he adds.  

As well as providing confirmation of a medication's safety and efficacy/effectiveness – which benefits patients and their compliance with taking their medicines – this type of data can give drug manufacturers a better understanding of the patients in which a treatment delivers the greatest benefit.  In turn, presenting this transparent information to the national healthcare systems will nurture a trust relationship and – as they can see the positive effects of the new medicine – they will be more likely to get best and appropriate use of that drug.   And once the journey of care is demonstrated clearly and understood, the true value of the new drug can be seen.  Says Dr. Parkinson, “You can then look at different ways of potentially saving the health system money: by stopping people being hospitalised, reducing the need for additional treatment, and reducing length of stay in hospital. All of these are ways that can add value to your product.”

When data becomes information

The use, and the availability, of RWD in the more progressive healthcare systems to determine how cost-effective a new product is, is rapidly advancing.  National and large private clinics and institutes worldwide have improved their data infrastructures to enable more dedicated research into the total cost of care and the related health outcomes of the drugs provided, forcing pharma companies to respond in kind.

In order to make sense of this expanding resource pool of data, Dr. Parkinson says that the key to effective RWD is electronic health records and the scope of which the records cover, total care – primary care, secondary care and other specialist care.  “The closer you get to a full electronic record, which is linked inside the National Health Service (NHS) in the UK, the better the data is.”

“Separate data sets can be linked together so that a particular view of the full pathway of the treatment can be created and subsequently evaluated. A unique patient identifier is essential in this structure as whenever a patient moves, their record moves with them to their new circumstances,” he says.  

Notable recent advances by the public health services in the US, France, and Germany are moving their own markets toward the already established electronic data structures in the United Kingdom, Australia, and Sweden.  Dr. Parkinson agrees that the UK has extremely efficient and well coded primary data sets, but notes the industry is also encouraged to move forward.

“Research is fundamental to ensuring the delivery of good clinical care.”

“We have a very good hospital data set with ICD10 codes and procedural codes but we are looking forward to sometime in the future to a full electronic health record which includes more information on what actually happens to people when they’re in hospital – coding by bedside,” he says.  

The way forward

With many countries now leaning towards value-based pricing and demanding that drug companies accurately and transparently show the value of their medicines, generating and analysing data that can be used to establish the value and thereby justify the release and retention of a product of treatment has become imperative. Greater knowledge of the patients who are using a particular medicine and actively striving to improve the benefit that patient receives also helps to strengthen customer/healthcare provider communication and relationships.

As such, the use of real world data for research is crucial for drug development and cannot be categorised as a secondary use of data, according to Dr. Parkinson. “It is a prime use because improvements in everyday clinical care come from research and therefore research is fundamental to ensuring the delivery of good clinical care.  It’s a long side clinical care to ensure the health care system is delivering best and most appropriate care under all circumstances,” he concludes.