Why is the Pharma Industry Buzzing About Real-World Evidence?
You have almost certainly heard the terms Real-World Data
(RWD) and Real-World Evidence (RWE) – but are you still unsure about exactly
what these things are and why they’re important? Let’s break it down.
Real-World Data (RWD)
is healthcare information that comes from outside the clinical research
setting. It includes data like:
- Electronic health records (lab results, treatment plans, radiology images, etc.)
- Disease and product registries (e.g., Alzheimer’s Prevention Registry, GenomeConnect, Rare Disease Registry Program)
- Claims and billing data (for example, data from health insurance companies that includes information about procedures and demographic information)
- Data from “wearables” and health monitoring devices (e.g., heart rate tracking from an Apple Watch or Fitbit)
Real-World Evidence (RWE)
comes from analyzing the above-mentioned types of data. In short, real-world
evidence = real-world data + analytics.
What is Driving the Interest in Real-World Evidence?
Here are a few major factors contributing to the
pharmaceutical industry’s excitement about RWE:
1) Because regulators take RWE into account, it has the
potential to impact approvals and accelerate the drug development process,
which could save drug makers a lot of money at a time when cutting costs is
critical. One such example comes from Amgen
Science, which had a cancer therapy that won its first regulatory
approval due to a single-armed Phase 2 study supported by RWE.
2) Real-world evidence complements clinical trials data by
providing insights that trials can’t – for instance, safety and effectiveness
data from a patient’s daily life. “Sometimes surprising findings can emerge
when the narrow constraints of clinical trial eligibility and intent-to-treat
analyses are set aside,” explains Nancy A. Dreyer in Stat
“That’s why it’s time for biotech and pharmaceutical companies to pay more
attention to understanding, and undertaking, real-world studies.”
3) It is important to insurance companies and other
stakeholders that they have a solid understanding of what benefits a drug
offers to patients, and RWE can help bolster their confidence in a treatment’s
effectiveness. “Insurance companies, particularly in the U.S., are looking for
medicines that can demonstrate improved patient outcomes and reduce
hospitalization rates and length of stays,” notes Ed Miseta of Clinical
Coming Up Next
In an upcoming series of posts on this blog, we will
discuss real-world evidence in more depth, covering its impact in the industry,
the regulators’ perspective (e.g. EMA, FDA), pharma’s perspective and more