Real World Evidence
Healthcare payers, including national governments, continue to face enormous cost and capacity challenges largely as a result of increasing demand from growing numbers of older people with multiple, complex conditions and the rise in non-communicable lifestyle diseases such as diabetes. Treatment costs are rising alongside this, partly due to the challenges in developing products which are targeted at complex disease states and patient sub-populations. In order to continue delivering the best possible outcomes for patients, it is vital that new ways are found to enable therapeutics to be brought to market at a sustainable cost.
Opportunities presented by Real World Evidence
Healthcare data present a unique opportunity to develop real world evidence insights into existing diagnostic and treatment pathways, to identify unmet need and to demonstrate the actual clinical and economic impact of interventions within the healthcare system. This evidence enables R&D organisations to prioritise their pipeline investments more effectively, better understand underlying causes of disease and identify opportunities for indication expansion and business development. It allows commercial organisations to demonstrate the clinical and economic value of their products to payers, to deploy health solutions that truly integrate healthcare and therapeutics and to build new reimbursement mechanisms.
Real World Evidence: Transforming patient care (1.18MB PDF)
Building stakeholder trust in use of health data
The development of real world evidence is therefore essential to sustain improvements in patient outcomes - yet there are significant privacy concerns regarding the sharing and use of health data for this and other purposes. Transparency and communication of the benefits of real world evidence is essential but insufficient alone to reassure sceptics. In order to build further trust across all stakeholder groups, including patients, payers, providers, clinicians, academics, regulators and the pharmaceutical industry, a mutually accepted process with governance is required for the use of health data to generate real world evidence.
Good Clinical Practice (GCP) is an established and successful standard that gives the confidence necessary for clinicians to prescribe and patients to follow treatments developed through clinical trials. Given the acceptance of GCP, Deloitte believes that an analogous approach should be developed to guide real world evidence studies. We have termed this approach Good Evidence Practice (GEP)
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