On May 20th, the international HEOR community of roughly 4,000 stakeholders from more than 80 countries will fill the Hynes Convention Center in Boston to discuss Evidence and Value in a Time of Social and Policy Change as part of ISPOR’s 22nd Annual International Meeting. As a long-time advocate of RWE “evolution”, or the growing need to overhaul our healthcare evidence development ecosystem into a more relevant and economically sustainable model – I couldn’t be happier about the topic.
For nearly two decades, ISPOR has served as one of the most important driving forces for health economics and outcomes research globally. ISPOR has not only championed the advancement of methods around real-world evidence development, but its leaders and members have worked tirelessly to educate themselves and the public of the importance of advancing real-world evidence development and its use to support day-to-day decisions.
The current sentiment for higher quality real-world evidence has risen to a never-before-seen level, with clamoring voices of payers, patients and providers alike. The milestone progress we’ve made as a nation is worth noting.
Over the last 10 years, we have seen the Food and Drug Administration (FDA) implement a handful of initiatives aimed at improving our ability to generate and utilize more relevant and timely medical evidence. HealthCore has had the privilege of working alongside many passionate members on accomplishments such as Sentinel Initiative, and programs and collaborations like EvGen, PCORI, PCRN and NEST.
Congress has become even more involved through inclusion of language within the 21st Century Cures Bill that requires FDA to issue guidance related to modern trial designs and evidence development. It is likely there will be similar requirements within the upcoming Prescription Drug User Fee Act version VI, requiring FDA to continue the exploration of the use of real-world evidence in regulatory decision-making.
For nearly two decades, like ISPOR, HealthCore has been and will continue to be a driver of innovation and RWE development. More recently, our commitment to and investment in expanding into large-scale real-world studies has begun to demonstrate success. Twenty years ago, the pragmatic trial was a kind of mythical creature, with these designs few and far between. This spring, we will be implementing our second pragmatic trial within our Integrated Research Environment, with the next phase of enabling research environment expansion set to begin in July.
Though the exact location of our nation along the developmental curve for a real-world evidence infrastructure is hard to determine, it is certainly on the upslope with momentum growing rapidly. We are truly looking forward to this exciting period in evidence development.