How will the drug behave in the complex, unpredictable real world?
For decades, randomized clinical trials have been the gold standard for demonstrating a potential new medicine is safe and effective. Nowadays, however, payers, policymakers and suffering patients are demanding more.
As the research and healthcare landscape shifts towards increasing personalisation of treatment, rising emergence of rare diseases and earlier access, it is simultaneously grappling with the challenges posed by the high costs and lengthy timelines of delivering medicines to patients. Real world evidence has the potential to help facilitate access and address some of this burden, whilst also providing a better understanding of medicines use in the ‘real world’.
In which patients it will be most effective? How does it compare with other treatments? How cost-effective is it? How much will it cost to treat everyone who needs it?
Rather than just looking at the effects of the drug in a controlled (RCT) environment, we need understand what happens in actual clinical practice and use that to inform treatment and reimbursement decisions.
Through big data we can now find a better understanding of how prescription drugs are being used by physicians and patients in clinics, hospitals and patients’ homes across the world.
Read the Publications:
September 4, 2018
Accelerated patient access pathway
The FDA is now focused on identifying additional areas in which RWE may be used to generate evidence of a therapy’s effectiveness. The FDA continue to encourage the use of RWE to drive for far richer, far more diverse, and more informative evidence.
In England, the National Institute for Health and Care Excellence (NICE) appraises the clinical and cost-effectiveness of newly approved therapies and issues recommendations for public coverage in the National Health Service (NHS)
A representative of everyday clinical practice
RWE can provide a window into how therapies perform differentially across endpoints and subpopulations and against expectations. In essence, understanding the real-world performance of individual therapies allows for the development of better product profiles and performance thresholds to inform the payer value conversation.
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The impact of real world data
Real-World Data (RWD) are data relating to patient health status
and/or the delivery of health care routinely collected from a variety of sources. These sources provide reliable evaluations on three pillars of RWE Studies.
RWE analytics delivers valuable information, from the frontline of healthcare systems. This data leads the conversation with payers, healthcare providers, and regulators to make more holistic, rational healthcare decisions.
Improved data collection enables safer studies with significantly larger study populations whilst upholding gold standard patient care and integration.