Real World Evidence (CTS-0150)

Spring 2025 · CTS 0150 · Tufts University · 1 credits · Undergraduate

This course serves as an introduction to topics in the use of real world evidence (RWE) to inform healthcare decision making. While randomized controlled trials remain the gold standard for establishing treatment efficacy, RWE offers many advantages including the availability of timely data at reasonable cost, large sample sizes that enable analysis of subgroups and rare outcomes, and increased generalizability to real-world clinical practice and more representative patients. Enthusiasm for RWE is tempered by concerns including those related to misclassification or data quality, the lack of randomization and other biases, and spurious data-driven findings. This course will introduce the foundational study designs and analytic approaches that are integral to the valid and efficient analysis of RWE, including those relevant to “big data.” RWE frameworks and approaches to be discussed will include limiting bias in observational big data, harnessing RWE for predictive analytics, identification of heterogeneity of treatment effects, pragmatic trial designs and the role of RWE for various stakeholders, including regulators. The potential role of RWE for the regulatory approval of novel therapies will also be discussed. Topics will be illustrated through the use of contemporary case studies representing both the promise and limitations of using RWE to inform healthcare decision making.

Course codes: CTS-0150, CTS 0150, CTS0150, CTS-150, CTS 150, CTS150

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