The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has released the “Guidelines for Disease Registry-based Real-World Data Application (trial)”. These guidelines are designed to steer the utilization of real-world evidence (RWE) in supporting regulatory decisions related to drugs.
Disease Registry and Data Quality
The document highlights that disease registries are typically established prospectively for registration purposes, gathering data on diseases and clinical characteristics of specific populations with a focus on quality control during implementation. Recognized for their relatively high data quality, these registries are a significant source of real-world data (RWD). The data from these registries can be applied in various scenarios, including generating clinical evidence, aiding in clinical trial design, serving as external controls for single-arm trials, and supporting natural history research and post-marketing evaluations.
Establishment and Evaluation of Disease Registries
The guidelines clarify the process of establishing disease registry databases and the methods for evaluating registry data. It is essential to consider the adequacy, applicability, and accessibility of data sources when constructing these databases. The document notes that treatment drugs or methods are generally not specifically limited during the construction process. Clinical endpoints for certain disease studies should be determined based on clinical issues. Attention to data quality control and security is paramount when obtaining and entering data into the registry. The document also emphasizes the positive significance of patient participation in disease registries and suggests integrating the concept of patient-centered drug development (PFDD) into disease registry and related research.-Fineline Info & Tech
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