To improve patient outcomes and make health care delivery more effective and efficient, all health care stakeholders must be able to access, use and communicate high-quality, real-world evidence.
What is real-world evidence, and why does it matter?
Understanding how treatments work in the real world is an important and complex task to guide care in real-world, clinical practice environments. When done correctly, real-world evidence can provide meaningful information; when done poorly, misinterpretations and poor health outcomes for patients are possible. The National Pharmaceutical Council has been playing a leading role in encouraging the use of high-quality methodology and standards to conduct real-world research and helping decision-makers understand how to evaluate and use real-world evidence.
Real-world studies investigate what treatments work best in the real world under usual care settings, instead of highly controlled environments like clinical trials. Real-world evidence can be collected from electronic health records, administrative claims databases and patient registries. While this evidence provides useful information, challenges exist. It’s difficult for health care decision-makers to analyze and use the data without the proper tools; it’s challenging for researchers to access the necessary databases; and it’s perplexing for the biopharmaceutical industry to communicate it because of ambiguous regulations. NPC’s research addresses each of these issues.
Using Real-World Evidence
Is high-quality, real-world evidence being used to inform health care decision-making? In the "real world," patients have characteristics and treatment experiences that often differ from the controlled environment of clinical studies. NPC's research has examined how decision-makers view this evidence and the challenges to its broader use.
Standards for Real-World Evidence
Do decision-makers know what “good” looks like? Good data and widely agreed upon research methods must be the basis for developing and appraising high-quality, real-world evidence. NPC’s work answers these questions, and offers online training, tools and checklists to evaluate real-world evidence.
Accessing Data
Why is broader access to real-world evidence data important? Whom does it benefit? What challenges remain? NPC takes a closer look at the limitations that can make it harder to conduct high-quality, real-world studies, and offers ways to reduce barriers to access while addressing privacy issues.
Communicating Evidence
It's important for all stakeholders to work together to better understand and communicate complex data about how treatments work in the real world. What are the constraints to sharing evidence? Who is allowed to talk about the evidence, and when? NPC's work addresses the existing barriers to communicating evidence, and considers changes to the U.S. Food and Drug Administration's current, ambiguous regulations.
