Real-World Evidence Complements Randomized Controlled Trials In Clinical Decision Making

Randomized controlled trials (RCTs) are considered the gold-standard study design for comparative effectiveness research, which involves directly comparing the effectiveness of one treatment to another. Despite their many benefits, RCTs have important limitations that can reduce their utility for certain types of comparative effectiveness research and limit the external validity of their findings. For this reason, real-world evidence—data about outcomes in actual patients who are receiving a treatment in a usual care setting—is gaining traction as a key source of evidence for comparative effectiveness research. In this post, we review how evidence generated by RCTs compares to real-world evidence, discuss when and why these two study types may yield different outcomes for comparative effectiveness analyses, and examine why real-world evidence is particularly useful as a complement to RCT data. Efficacy Versus Effectiveness The US health care system’s shift from volume- to value-based payment models has heightened stakeholders’ focus on measuring care value accurately and reliably. Care value is, fundamentally, a function of quality and costs of care for real-world patients, not patients in clinical trials. Thus, policy makers, payers, and health system leaders have grown increasingly interested in finding ways to estimate reliably how given treatments will affect care quality and spending in real-world patient populations. Both RCTs and real-world evidence can...
Source: Health Affairs Blog - Category: Health Management Authors: Tags: Drugs and Medical Innovation chronic disease comparative effectiveness research efficacy-effectiveness gap health care innovation measuring care value randomized controlled trials real-world evidence Source Type: blogs