What inherent risk is higher in observational RWD analysis compared to a randomized trial?
Answer
Confounding variables
The primary methodological hurdle when analyzing Real-World Data (RWD) is ensuring the trustworthiness and reproducibility of conclusions, largely due to the observational nature of the data collection. In this setting, the risk of confounding variables is inherently higher than in a Randomized Controlled Trial (RCT). Confounding variables are extraneous factors that influence both the choice of treatment received by a patient and the final outcome, potentially creating misleading associations. To combat this, researchers must apply advanced statistical techniques, such as propensity score matching, to meticulously adjust for these observable differences between treatment groups.
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