Real world evidence (RWE) – a disruptive innovation or the quiet evolution of medical evidence generation?

Abstract

Stakeholders in healthcare are increasingly turning to real world evidence (RWE) to inform their decisions, alongside evidence from randomized controlled trials. RWE is generated by analysing data gathered from routine clinical practice, and can be used across the product lifecycle, providing insights into areas including disease epidemiology, treatment effectiveness and safety, and health economic value and impact. Recently, the US Food and Drug Administration and the European Medicines Agency have stated their ambition for greater use of RWE to support applications for new indications, and are now consulting with their stakeholders to formalize standards and expected methods for generating RWE. Pharmaceutical companies are responding to the increasing demands for RWE by developing standards and processes for each stage of the evidence generation pathway. Some conventions are already in place for assuring quality, whereas other processes are specific to the research question and data sources available. As evidence generation increasingly becomes a core role of medical affairs divisions in large pharmaceutical companies, standards of rigour will continue to evolve and improve. Senior pharmaceutical leaders can drive this change by making RWE a core element of their corporate strategy, providing top-level direction on how their respective companies should approach RWE for maximum quality. Here, we describe the current and future areas of RWE application within the pharmaceutical industry, necessary access to data to generate RWE, and the challenges in communicating RWE. Supporting and building on viewpoints from industry and publicly funded research, our perspective is that at each stage of RWE generation, quality will be critical to the impact that RWE has on healthcare decision-makers; not only where RWE is an established and evolving tool, but also in new areas that have the potential to disrupt and to improve drug development pathways.

Real-World Assessments of mySugr Mobile Health App

“…Nevertheless, many health care providers with product developers and regulatory agencies recognize the inherent limitations of RCTs in providing real-world evidence (RWE) about the impact and efficacy of medical devices in clinical practice, and an increasing number of payers and regulatory agencies are now focusing on RWE in combination with RCT findings to inform their decisions. 34 The data presented here will be utilized to generate future research hypotheses to further test the clinical utility of my-Sugr's integrated diabetes management solutions and to improve the mySugr app and diabetes management tools. Additionally, the observations and conclusions will inform the design of future prospective observational and interventional studies.…”

Health Care and Pharmaceuticals 2020: Key Factors, Expected Trends and Way Ahead

“…Now with companies specializing in generating RWE for the pharmaceutical industry, the trend is increasingly going to shift towards RWE based promotion and communication. 16 RWE will also be an important factor for several herbal and nutritional supplements which have been launched for allopathic co-prescriptions in many chronic diseases. The HCPs and the pharmaceutical industry have a symbiotic relationship in RWE generation with the former helping in effective data generation in clinical practice and the latter designing its capture, regular and effective analysis and sharing of inferences through scientific meets, publications and communication with HCPs.…”

A Digital-First Model of Diabetes Care

“…[16][17][18][19] Recognizing the inherent limitations of RCTs in assessing the use and efficacy of medications and technologies in every-day life, a growing number of stakeholders (e.g., regulatory agencies, payers, and clinicians) are turning to realworld evidence in conjunction with RCT data. 20,21 Moreover, much of the current evidence in diabetes is, in fact, much stronger than any link to improved outcomes associated with general health information technologies, such as electronic health records, which inexplicably require little or no return on investment, and appear to be driving physician burnout. [22][23][24] A Digital Model of Diabetes Care If patients do use an app in their own care, it is often done independently of their care provider, who cannot deal with the rapid pace of the development of apps and the extra data points they can generate.…”