What Are Real-World Evidence and Real-World Data? 

By: Pamela Landsman-Blumberg, Jessica Duchen, Michael (Mike) Murphy

Our ability to generate data has, and continues to, undergo exponential growth over the course of our lives. As our data universe expands, we seek new and innovative ways to improve our everyday lives. One industry of focus includes healthcare, where researchers, pharmaceutical companies, payers, physicians, and more are constantly working to improve patient outcomes and experiences. Aiding in this work has been the incorporation of real-world data and real-world evidence to the traditional randomized clinical trial (RCT) data.  

What is Real-World Evidence (RWE)? 

RWE is the evidence or insights derived from the analysis of real-world data. 

RWE can be generated through the analysis of data from a variety of sources, including RCTs, observational studies (retrospective and/or prospective), and pragmatic trials, as examples. RWE is frequently used to demonstrate clinical benefits and/or risks associated with medical therapy. 

What is Real-World Data (RWD)? 

RWD is defined as “the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources.” 1

RWD can be sourced from a variety of places, including, but not limited to: 

  • Electronic medical record (EMR) or electronic health record (EHR) 
  • Claims and billing information 
  • Disease registries 
  • Patient-generated, such as: digital therapeutics (DTx), apps, and wearables (eg, smartwatches) 

What’s The Difference Between RWE and RWD? 

If you’ve been around healthcare research recently, you’ve likely heard the terms “real-world data” (RWD) and “real-world evidence” (RWE) used interchangeably, however, it is important to note that, while these are highly related, they are 2 distinct concepts.  

As an example, imagine wearing a smartwatch. While being worn, your smartwatch will continuously collect information on your heart rate. This raw heart rate data is RWD. Now imagine that you are logging workouts with your smartwatch. Your smartwatch might give you information on your average heart rate during a workout, or over multiple workouts, and may even give you information on the intensity of your workouts over time. This would be considered RWE.  

Importance of RWD and RWE in Healthcare 

RWD enables deeper and expanded insights into medical conditions and their treatments, beyond the RCT. RWE is frequently much more cost-effective, capable of generating insights quicker, and includes more diversity in population and treatment patterns than a clinical trial. While RCTs remain the industry gold standard for evaluation of new medical therapies, they also tend to lack the context and complexity that patients will face in their daily lives as they, and/or their caregivers, manage their health and treatments. RWE can provide critical insights into how treatments perform in subpopulations that may not have been studied within a standard RCT. For example, RWD can be collected and analyzed for populations with varying levels of comorbidity, age, and other sociodemographic factors (eg, race and access to healthcare). RWD also provides researchers with the ability to glean insights into disease and treatment characteristics across a patient’s lifetime, not just the period included in the RCT.   

The FDA recently updated its guidelines on the use of RWE in support of regulatory decision-making in addition to using RWD and RWE for post-market safety and adverse event monitoring.2,3 

RWD and RWE are used to inform decision-making across the healthcare industry by a variety of stakeholders, including: 

  • Physicians and healthcare professionals 
  • Life science researchers and biopharmaceutical companies 
  • Health plans and payers 
  • Policy makers and regulators 

What Should I Consider When Using RWD and RWE? 

Since RWD can be obtained through many different sources and originate from many different stakeholders (eg, physician, patient, etc), the rigor and quality of data generation, collection, and cleaning can vary widely from source to source. In other words, users of RWD must carefully consider both the reliability and relevance of RWD prior to use for insight generation. Insights gleaned from data, especially RWD, can only be as good as the RWD used to generate them.   

Real-World Evidence and Magnolia Market Access 

Interested in learning more about how utilizing RWD and RWE can supercharge your market access strategy? Concerned that your current RWD sources are not adequately meeting your needs? Our experts are happy to discuss fit-for-purpose RWD- and RWE-driven approaches to meet your company´s unique needs and optimize your roadmap. 

  1. https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence  ↩︎
  2. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-real-world-data-and-real-world-evidence-support-regulatory-decision-making-drug  ↩︎
  3. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/real-world-evidence-considerations-regarding-non-interventional-studies-drug-and-biological-products   ↩︎