Why is the Pharma Industry Buzzing About Real-World Evidence?

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
News
.
“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
Leader
.

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

bhajavas

Leave a Reply

Your email address will not be published. Required fields are marked *