How Real-World Evidence (RWE) is Changing the Pharma World

From ‘big data’ to RWE

In one form or another, talk about data has rippled through the life sciences and pharma industries for years. At first, the term ‘big data’ demanded the attention of top level management; this coincided with the rise of the internet and data-driven policy-making.

Since then we’ve graduated to the terms Real-World Data (RWD) and Real-World Evidence (RWE). These terms entered the collective consciousness relatively recently, and they haven’t gone away since. If anything, the hype surrounding Real-World integration with the pharma world has continued to grow.

Digital technologies have provided us with the ability to swiftly and efficiently collect, store, analyse and transmit data. These data have unlocked huge potential in clinical development, customer engagement and patient safety.

Real-World is a reality

The use of RWD sources include prospective observational or registry studies, retrospective database studies, case reports, and electronic health records.
This use of RWD to generate RWE is no longer a novel idea. Real-World is now a reality – across both national and commercial entities.

Talking to The Pharma Letter, Dr Páll Jónsson (left), senior scientific advisor at the UK’s national health watchdog NICE (National Institute for Health and Care Excellence), says that: “The traditional role for RWD is to support RCT data. We have, for a long time used RWD to help understand whether clinical trial data can be generalised to our patient population. We’ve also used it to extrapolate health outcomes data beyond the timeframe of RCTs.”

What can RWE do?

There are several ways in which RWD can help to support RCT data collection, improving value for pharma. RWE can help us understand the natural history of diseases and the relative effectiveness of treatments already being used practice. There is also a potential role for RWD where RCTs are not feasible, such as in rare disease.

A substantial application for RWE has also arisen in the area of market access. Here data can be used to communicate an effective value proposition to payers and healthcare providers.

Increasing regulation and budgetary pressures have fuelled the rise of budget impact models, cost effectiveness calculators, and similar tools for market access, delivered using mobile technology that integrate large datasets.

The randomized clinical trial is justifiably the gold standard in establishing safety and efficacy, though it has long been known that the data from RCTs can, and should be supplemented by other data sources. The pharma world is now open to use of these data-sets, and Ignite Data are working to ensure these strategies work effectively.