Gemma Hoyle, Senior Research Executive, Research & Insights.
Real World Evidence: ‘Nothing new, but new to some’
Transforming the landscape of how treatments reach patients
WHAT IS RWD…?
Let’s start with re-capping what RWD is – it’s often defined as any data not captured via randomized controlled trials: Health records | Diagnostic data | Claims data |Lab/biomarker data | Registries | Mortality data |Pharmacy data | Patient generated data e.g. wearables, social media. We collect the data via a market research survey, then analyse and report. Often, the results lead to scientific publications (as well as regulatory submissions!).
In summary, RWD is real patients, taking medications in their real lives. We don’t intervene, just observe. It makes sense why regulators are looking towards RWD for clinical evidence.
“As the breadth and reliability of RWE increases, so do the opportunities for FDA to make use of this information.” Scott Gottlieb, prior FDA Commissioner FDA.gov, 2017
On a bigger scale, The National Institutes of Health (NIH) Common Fund has been established to build an infrastructure that will incorporate electronic health records (EHR) and other real-world data into large-scale distributed research networks, allowing researchers the opportunity to access data and studies more easily. These data centres are popping up everywhere – see FlatIron Health for a great example.
A couple of examples we’ve read about provide us with a flavour of what pharmaceutical companies are doing with RWD (please note, we had no role in these projects and this is not intended to be promotional).
- In 2018, Astra Zeneca used RWE to identify the need for better secondary prevention in a high-risk population
- This year, Pfizer used RWE to expand an indication to include men with breast cancer
This is transforming the landscape of how treatments reach patients. You can imagine what RWD is doing for rare disease and gene therapy!
As a researcher, I put my hands up and admit I LOVE data; I feel passionate about the importance of data being as accurate as possible. RWE is a great step towards this so I’m really excited to see that regulators like NICE and the FDA see the value.
Our experience spans across neurology, infectious disease, diabetes, rare disease, psychiatry and oncology and we’ve covered the EU5, America, Asia and Australia. If you’d like to hear more about our RW studies email me on Gemma.Hoyle@ashfieldhealthcare.com.