The Evolving Demands for Real-World Evidence
The needs for higher quality and timely real-world evidence has risen to a never-before-seen level, with the clamoring voices of payors, patients and providers alike expressing, often in unison, the need for such evidence to help determine the highest value treatment for the right patient, at the right time.
The milestone progress we have made as a nation is worth noting as well as a look ahead in terms of how real-world evidence will evolve, and the stakeholders who will influence its evolution, moving forward.
Over the last 10 years, we have seen regulatory agencies such as the U.S. Food and Drug Administration (FDA) implement initiatives aimed at improving our ability to generate and utilize more relevant and timely medical evidence. Congress has become even more involved through inclusion of language within the 21st Century Cures Act that required the FDA to issue guidance related to modern trial designs and evidence development. HealthCore has had the privilege of contributing to these efforts via the Sentinel Initiative, and participations in collaborations like EvGen, PCORI, PCRN and NEST. HealthCore has been in the forefront of both the innovation and implementation of some of the nation’s largest pragmatic clinical trials to date.
Looking ahead, the urgent need of real-world evidence to help address questions of therapeutic value post regulatory approval will continue to mount. Payors, providers, and patients have an increasing need for more timely evidence that utilizes real-world observational data that can inform decisions regarding appropriate access, treatment decision, and treatment use respectively. In no area has the evolving demand for real-world evidence been more pronounced than in the area of oncology where the volume of novel, expensive and life-saving therapies outstrips traditional evidence pathways to evaluate their relative value. The ongoing evolution of real-world evidence capabilities that leverage innovative research methods, study designs, and real-world observational databases to help address questions of clinical effectiveness and therapeutic value for novel oncolytic therapies relative to a constantly changing treatment landscape will be critical.
For nearly two decades, the Health Economics and Outcomes Research (HEOR) team at HealthCore has been an innovator and driver of real-world evidence development based on the unique blend of multidisciplinary research expertise, relationships, and access to real-world observational data. Through this combination, HealthCore’s HEOR team is able to generate evidence to help articulate therapeutic value from the perspectives of payors, providers, and patients using resources that enable more rapid generation of insights, underpinned with rigorous research expertise and sophistication.