Six unique challenges posed by RWE in Regulatory decision making
Real-world evidence raises different considerations in the context of regulatory decision-making which depends not only on the evaluation of the methodologies employed to generate evidence but also consideration of the reliability and relevance of RWD used to derive RWE.1 ■
Quality of real-word data sources
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Variability between different data sources
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Lack of essential data elements (lack of standardization in collecting data)
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Lack of standardization of RWE analytics
Quality of real-world data sources
The quality of RWE can vary significantly across sources. Lack of completeness in the data provided can have only limited value for the analysis intended to be performed to demonstrate sufficient statistical evidence.
Variability between different data sources
Methods are needed to address duplication of patient information and to link data about a single patient across data sources.
Lack of essential data elements (lack of standardization in collecting data)
Data sources such as EHRs and medical claims data may not capture all essential data elements needed to answer the question of interest. Different health care systems use EHRs in different formats that are not standardized making it difficult to collect data across varying records.
Lack of standardization of RWE analytics
Variation in analysis methodology, poor-quality analyses, limited transparency into methods, and bias in results still require standardization.
Publication of favorable results while excluding negative findings can be more serious with RWE studies than RCT, as registration of RWE studies in public registries/platforms are limited. Very few RWE studies are publicly registered with posting of complete results.
In many countries, access to RWD such as claims data, national health check-up data, and electronic medical record data are restricted.