In our ever-evolving health care landscape, both researchers and practitioners must consider innovative methods to advance the quality of care and improvement of patient outcomes. In recent years, the use of real world evidence (RWE) to influence decision-making, improve patient outcomes, and bridge the gap between clinical development and patient access has increased significantly with the greater availability and access to real world data (RWD) sources.
Although the definition of RWE is still evolving, the Food and Drug Administration (FDA) defines it as evidence derived from data collected from sources other than traditional randomized clinical trials (RCTs). RWD can be collected either prospectively or retrospectively from routine clinical practice and sources such as patient registries, electronic health records, pharmacy and health insurance databases, social media, patient-powered research networks, and observational studies.
Although RCTs are the golden standard for measuring treatment efficacy and safety, findings from RCTs might not be relevant to real-world practice. RWE can enhance the effectiveness of RCTs by helping to streamline refine, or supplement data derived from these trials without lowering the standard of evidence while ensuring the inclusion of outcomes that matter to patients, providers and others. RWE is becoming a critical success factor in product development throughout the lifecycle and supports clinical research by helping to inform the generation of focused hypotheses and design of RCTs. RWE can also facilitate operational aspects of drug development in optimizing patient recruitment by mitigating selection bias and improving patient access to data.
Using Data, Analytics and RWE to Develop New Insights at Sanofi
A value-based, patient outcomes approach is driving the role of RWE. With RWE we are able to tailor health care decisions to the needs of individual patients through a deeper understanding of drug performance in the real world.
Sanofi is invested in the potential of RWE improve care. Sanofi’s RWD platform houses data from 300 million patients worldwide representing 318 disease areas and has already delivered more than 40 RWE projects. An additional 209 projects are planned for 2018 across more than 11 therapeutic areas. RWE is becoming a strong enabler for maximizing Sanofi’s value for patients. For example, for its diabetes medication, Toujeo, Sanofi has implemented randomized pragmatic trials to complement the drug’s RCTs. Randomized pragmatic trials are a type of clinical study that measures the relative effectiveness of treatment strategies in real world clinical practice and allows for input from health systems, healthcare professionals, and patients. One such study, a December 2017 retrospective observational study used electronic medical records (EMRs) from the Predictive Health Intelligence Environment database to assess clinical outcomes of Sanofi’s Toujeo compared to basal insulins. Another utilized real world electronic health data from the Humedica database to validate findings from Toujeo’s RCTs and other real-world analyses.
Building the RWE Workforce
RWE has great potential to bridge the gap between clinical development and patient care. As interest in RWE utilization grows, there is an emerging need for RWE-focused training for the health services research workforce. Sanofi is proud to partner with AcademyHealth to offer the Real World Evidence Fellowship. RWE fellows working with Sanofi will focus on the use of real world evidence across a variety of functions including Real World Evidence and Clinical Outcomes, Epidemiology and Benefit-Risk, Patient Solutions and Medical Strategy. The fellows will have the opportunity not only to learn advanced approaches in RWE, Epidemiology, Structured and Quantitative Benefit-Risk evaluation, advanced analytics, and health/patient behavior but also to learn how to implement this in the biopharmaceutical setting, an experience not often available from academic environments.
With increasing emphasis on using RWE across the entire product lifecycle, there is a distinct advantage to building a workforce skilled in the management and analyses of RWD. Researchers with solid experience in clinical trials as well as a strong orientation to the needs of real world studies and the peculiarities of RWD are poised to make a significant impact on moving evidence into action more effectively.