Despite its benefits, RWE comes with its own set of challenges:
Data Quality: Variability in data sources can lead to issues with data accuracy and completeness. Bias: Observational data can be subject to various biases, including selection bias and measurement bias. Regulatory Acceptance: While regulatory bodies are increasingly recognizing the value of RWE, there are still hurdles in its acceptance for drug approval and labeling changes. Data Integration: Combining data from multiple sources can be technically challenging and requires robust methodologies to ensure consistency and reliability.
