The focus of the healthcare industry has shifted from being solely dependent on medical interventions to encompassing additional factors that can continually help deliver quality patient care. These factors include genomics; behavioral and environmental influences; claims and billing data; and patient data from registries and medical applications, which together comprise real-world data (RWD).

Analysis of these massive pools of RWD provides real-world evidence (RWE) derived from hundreds of millions of patients. RWE provides valuable insights, helps prepare for study shortcomings, and enables a better perspective across various therapeutic areas. Physicians, regulatory bodies, and pharmaceutical and medical device manufacturers rely on RWD to guide their decision-making.

The U.S. Food and Drug Administration’s (FDA) efforts to cross-link RWD and create a unified structure to monitor the safety of medical products, as well as initiatives by the National Institutes of Health (NIH) Common Fund to incorporate RWD into robust, easily accessible databases, are examples of efforts to improve data accessibility. These initiatives allow researchers to identify treatment limitations, target specific patient populations, and support informed decision-making.¹

RWE can better capture treatments in real-life settings, effectively characterize patients, and help us better understand new treatment methodologies when randomization may be impractical or when randomized controlled trials (RCTs) cannot provide the required data.

Countries such as Germany, France, and the Nordic nations have successfully generated nationwide databases; however, they lag behind due to uneven data quality and a narrow spectrum of RWD sources. Limited access to comprehensive RWD and a lack of standardized methods to analyze RWE undermine its broader usability. RWD initiatives also need to confirm the elimination of biases, improved data quality, and broad data representation.² A significant challenge remains in convincing stakeholders that the benefits of RWD outweigh the risks associated with sharing sensitive patient information. However, these barriers can be overcome through concerted efforts by stakeholders across the entire healthcare value chain.³

As RWE becomes increasingly accepted, it is expected to become integral across a product’s lifecycle. Additionally, with improved methodologies and greater clarity, RWE analysis could help support therapeutic efficacy, generate tailored treatment solutions for specific patient cohorts, and fulfill post-marketing requirements.

We at CBCC (now REV Clinical) aim to shape an integrated, adaptive ecosystem by strengthening academic collaborations that provide access to novel data sources. Since its inception in 1984, the organization has continually expanded to become the largest freestanding, privately held cancer research center in the nation and was the first center globally to implement Electronic Medical Records (EMR) with Varian Medical Systems. The organization later joined forces with Dignity Health and, since 1996, has been associated with the UCLA community research network to provide cancer care to the community.

REV Clinical envisioned the digitalization of healthcare systems and collaborated with Mendel AI in 2017 to convert its extensive EMR data into research-ready, analyzable datasets. The organization has onboard subject matter experts who are adept at developing RWE strategies, successfully leading the execution of RWE studies, and effectively communicating study results. CBCC (now REV Clinical) has also built platforms to analyze robust datasets in a rapid, cost-effective manner, leading to reduced turnaround times, increased feasibility, and credible study outcomes.

References

1. U.S. Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. August 31, 2017. U.S. Food and Drug Administration. Available at: fda.gov
2. Barham, L. Real-World Evidence for Pricing and Reimbursement: The Potential of SACT Data. Pharmaphorum. January 15, 2015. Available at: pharmaphorum.com
3. Sherman, R. E., Anderson, S. A., Dal Pan, G. J., et al. Real-World Evidence — What Is It and What Can It Tell Us? New England Journal of Medicine. 2016.