Real-world Evidence is should be the pilot of new drug development, and it's already a business class priority. So why is so much RWE thinking still flying economy?

Real-world Evidence presents an opportunity to transform the way drug development works. In the wider context, Big Data has already changed data rich sectors such as Retail, Travel and Financial Services beyond recognition, reducing costs and improving returns while also having a leveling effect – it’s not how much data you have, it’s how you generate insights which become the key competitive differentiator. These sectors have become expert at joining up disparate data sources and making sense of them. Healthcare is much further behind.

In drug development, Health Economics and Outcomes Research professionals, including Epidemiology teams, are struggling to fully identify and understand the possibilities. This is in part to the fragmented, regional or geographical based state of Real-world Data, that it is frequently incomplete and can be hard to correct for reporting bias. It’s not easy to access either, particularly in Europe, and the uptake on Real-world Evidence by health technology assessment agencies isn’t uniform.


As development becomes increasingly a multidisciplinary process, discussions where the data narrative should be more embedded, particularly in brand teams, are much earlier and contribute to the direction of both pipeline assets, and the studies undertaken to gather data evidence inside and outside clinical trials. So RWE provides not only an opportunity to reduce costs in development, and ensure that investments in late stage trials are on track to support access, but it strengthens the seamless narrative about efficacy and value in a way which the rise of Medical Affairs departments was intended to achieve.

If translational research could incorporate an RWE focus, it would bring clinicians into the development process early enough to provide real ballast for the evidence generated through observational studies. In the time it could lead to a more balanced scorecard – placing real world observational data on the same standing as trials data. This, in turn, would promote faster adoption of RWD based evidence among agencies and regulators, further encouraging and accelerating collaboration around RWD capture, speed to access outcomes data (currently notoriously protracted and with consequences of its own) and the formulation of shared data standards and governance.

If data can fly me from Tokyo to New York the long way around, buying goods which will be delivered while I’m in the air, and paid for seamlessly through an integrated banking system, why is it so ambitious to see this seamless flow of data and ready accessibility in that most important of all journeys we undertake – our health?

Written by Kevin A'Court -  Head of Healthcare and Life Science Practice at Consulting Point