The life sciences industry is waking up to data without borders, or more precisely decision making about patients in which patients themselves are at the center of those decisions. I’m talking, of course, about Real World Evidence.
If we’ve met, or talked, you’ll know I only talk about one thing more than RWE, but that's my chronic motorcycling habit.
Take up on data captured outside Clinical Trials has been patchy so far, primarily used in monitoring safety. Pharmacovigilance was always going to be a point of proof for the concept, but look wider in healthcare systems and there is already potential to understand not only safety in the real world of patient behaviour away from a clinical setting, but working out what works, for whom, and what optimal looks like.
If the FDA extends its use of Real World Evidence beyond postmarketing surveillance, and concludes it beneficial for label expansions or new indications we might see the seeds of a really persuasive response to the pricing pressure being placed on pharmaceuticals manufacturers and the cost burden on healthcare systems. By enabling manufacturers to make the most of their development investments, and rationalise their pipelines to ensure optimal and guaranteed access to patients who will respond to treatments, the burden of discovery could be reduced.
The difficulty will be in untangling the variety and heterogeneity of real-world data types. EHR, Claims, Genomic, Phenomic, every kind of omic you could want, biobanks, laboratory test results, scrip data, credit card data, dietary information, and let’s not even get started on what wearables could add into the mix.. sedentary habits and correlations with diabetes anyone?
The sooner regulators set a precedent about the value of a holistic understanding of patients, expressed as a holistic view on evidentiary data, the sooner it will not only be doctors without borders, it will be medicines without waste and in time patients sans frontieres.
Written by Kevin Acourt - Head of Healthcare and Life Sciences Practice