Real-world evidence and clinical trials: What’s the difference?

As part of an ongoing series, we are taking a look at how evidence can help us identify the health and cost impact of treatments on patients, while also highlighting areas of unmet patient needs. Earlier posts can be found here, here and here.

Since we announced our partnership with HealthCore, we have been engaging in many conversations with payers, industry groups, policy leaders and other stakeholders about how best to collaborate on developing and applying real-world evidence to improve health outcomes and manage total cost of care.  A question often asked early on in these conversations is ”how do these kinds of studies differ from clinical trials?”

While randomized, controlled clinical trials are the regulatory standard by which safety and efficacy of drugs are demonstrated in the US, these studies often are designed with numerous controls that may limit the ability to answer questions related to the real world delivery of healthcare.  Studying the use of a drug in a real-world setting can yield insights into costs, optimum co-therapies, and medical best practices that are not available through clinical trials.

Brian Sweet, who is AstraZeneca’s executive director, health care alliances, distinguishes between randomized controlled trials and real-world evidence in the video above – an interview with the National Pharmaceutical Council.  Sweet emphasizes the importance of having a body of studies to look at in assessing the value of a particular therapy.