Real World Data (RWD) and Real World Evidence (RWE)
The growing trend throughout healthcare is the usage of Real World Data (RWD) to help develop new drugs, build Artificial Intelligence tools, and study patient populations is undeniable and is transforming all aspects of the healthcare industry. The FDA has even issued guidance on how to best leverage RWD to aid in drug discovery and monitor post market safety and adverse events for drugs. So what exactly is real world data and what does all of this mean for healthcare?
Real World Data (RWD)
Real World Data can be defined as any data collected in the context of the routine delivery of care. It is often contrasted with data collected specifically for research, often within the context of a clinical trial where the study design and data collection protocols improve ease of use but limit representation of real world care and outcomes.
RWD is derived from a patient’s health care journey through routine care or even outside of the healthcare journey (think of wearables, mobile devices, etc.). Common sources of RWD include Electronic Health Records (EHR), claims/billing, and labs data. What is included in RWD continues to expand as we look at patient-generated data including in home-use settings data gathered from wearables, mobile devices and even things like grocery store habits.
Real World Evidence (RWE)
Real World Evidence is the evidence and insights derived from analysis of real world data. So the analysis of real world data can generate real world evidence.
The potential benefits of leveraging real world evidence are enormous. Stakeholders across the healthcare ecosystem can use this new knowledge to support decision-making and improve safety, effectiveness, and ultimately, patient outcomes.
How Is Real World Evidence Used?
Real world evidence can be widely used throughout the healthcare system. From the physician’s office, to life science research, to health plans and payers, policy makers, and regulators, RWE can make an impact across the spectrum.
Life Sciences and Pharma
Life science researchers and biopharmaceutical companies are important stakeholders who can benefit from real world evidence as it can provide complementary insights into the safety and efficacy of novel therapies and medicines. Beyond the findings of traditional clinical trials, RWE can allow these organizations to analyze the broader impact of medication use in clinical care.
Policy Makers and Regulators
Real world data and evidence are valuable in enabling regulators to monitor post-market safety, make informed regulatory decisions, accelerate drug development, design value-based contracts, and evaluate innovation models for Medicare and Medicaid programs.
Health Plans and Payers
Health plans and payers recognize the value of real world evidence in informed safety monitoring, utilization management, cost/value analysis and to inform pharmacy and therapeutic committee decisions. High-quality clinical trials remain critical in payer decision-making, but payers are turning more frequently to RWE for greater validity in evaluating value-based care outcomes and tying payment for treatment to both short and long-term effectiveness of pharmaceuticals and other therapies.
Physicians and Healthcare Providers
Clinicians and providers are starting to quickly make use of RWE for clinical decision support and data-driven treatment decisions. Real world Evidence is a cutting-edge tool to empower clinicians to make targeted and appropriate treatment plans for their patients.
Moving from RWD to RWE
There are some huge barriers in transforming RWD to RWE, the largest of which is managing data quality.
In contrast to the typical clinical trial setting, there aren’t many checks in place to ensure that the data that’s brought in from a real world setting is clean and ready for analysis. This means that cleaning real world data is typically a cumbersome process (link to RWD Cleaning guide), and organizations tend to struggle with everything from data standardization to completely missing information.
Despite the challenges that RWD and RWE present, there is tremendous value to be unlocked in the data. A McKinsey article estimated that over the next three to five years an average top-20 pharmaceutical company could unlock more than $300 million a year by adopting RWE across its value chain. And that doesn’t account for the many non-monetary benefits such as accelerating the pace of scientific innovation.
