with a growing burden of disease, an ageing population, increased cost and capacity challenges, and increasing drug prices- there is an urgent need to remove inefficiencies to improve the delivery of care and patient outcomes. real world evidence could significantly improve healthcare decisions across the health system, ultimately improving patient care by creating an approach to healthcare in which all relevant data shapes decision making at both the government and point of care levels and in increasing value in our healthcare systems for regulators, HTA, payors, prescribers and patients. the capacity for RWE to address clinical and policy relevant questions that cannot be answered using data from clinical trials is garnering increased interest. and by using RWE, regulators can accelerate novel agents through the approval process and into the hands of patients.
but what is RWE exactly?
although a standard definition of RWE has not been uniformly embraced, the US Food and Drug Administration [FDA] defines RWE as ‘healthcare information derived from multiple sources outside of typical clinical research settings, including electronic medical records [EMRs], claims and billing data, product and disease registries, and data gathered by personal devices and health applications.’ RWE has only become achievable with cloud computing and technology which allows for the collection and analysis of data.
the FDA has suggested three main uses for RWE – the first from a regulatory authority standpoint that includes post marketing and adverse events surveillance to make regulatory decisions. secondly, RWE can support care decisions, assisting in the development of guidelines and tools that can aid in clinical practice. this approach can help decrease delays between time of diagnosis and treatment. thirdly, RWE can support clinical trial design and drug development by providing greater understanding of the actual usage and performance of a therapy in the real world; this view is important because the settings and circumstances within a controlled, clinical trial typically do not reflect the patient cohort and environment of those who will use the drug after its approved, in the real world.
this non-traditional approach to collecting data not only enables a variety of stakeholders to obtain new insights, to support value based care and deliver better health outcomes- it allows for providers of care to build better patient profiles and predictive models for diagnosing and treating disease. it creates a platform that allows patients to be more empowered and engaged in their health and healthcare decision making. today, more patients are becoming involved in their care, providing input and insights to their conditions. this shift will change the role of physicians and their relationship with the patient.
RWE can also be used to better serve patients and their needs within the hospital setting, by demonstrating the value of the therapy, highlighting inefficiencies within the process, identifying appropriate pathways for patient populations and providing real time evidence for physicians.
demonstrating value for therapies through RWE removes uncertainty for regulators and payors as well. it provides support to decision makers in a way that was not possible in the past. RWE can accelerate novel agents through the approval process including changes to labeling about drug product effectiveness; adding or modifying an indication; adding a new population; or adding comparative effectiveness or safety information.
it also creates knowledge that could advance research and drug discovery, deliver insights on therapeutic effectiveness and an understanding of special populations that would benefit and it allows for rapid analysis of the data in real time.
until we have an adaptive partner ecosystem that incorporates RWD and RWE, the potential of RWe can’t be fully utilized. collecting and implementing RWD and RWE today means that we can make a real impact for patients tomorrow. there is potential for real world evidence to transform healthcare realizing tremendous public health benefits.