RWE 101 – Is Real World Evidence a Replacement for Clinical Trials?

Real world evidence (RWE) is not a replacement for clinical trials. Clinical trials are considered the gold standard for assessing the safety and efficacy of medical treatments because they are designed to control for various factors that could influence the results, such as confounding variables and bias. In contrast, RWE is based on observations and data collected from real-world settings, where there may be many confounding factors that can affect the outcomes.

However, RWE can complement clinical trials by providing additional insights into the effectiveness and safety of medical treatments in real-world settings. RWE can help to identify potential safety concerns, as well as provide information about the effectiveness of treatments in patient populations that may not have been included in the clinical trials.

Furthermore, RWE can also help to inform the design of future clinical trials by providing information about the natural history of diseases and the characteristics of patient populations. RWE can also help to identify potential subgroups of patients that may benefit more from certain treatments.

In summary, RWE is not a replacement for clinical trials, but it can provide valuable complementary information to help inform clinical decision-making and optimize the use of medical treatments.

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