关键词:  , 医药临床试验；数联网；数据基础设施；智慧监管

Abstract:

Clinical trials play a critical foundational role in medicine field. Conducting medical clinical trials requires the exchange of clinical trial data among multiple stakeholders， including clinical trial institutions， pharmaceutical R&D companies， and regulatory authorities. This process faces challenges such as the diversity of data sources， ensuring the security of sensitive data， and the complexity of data flow and processing， which makes traceability difficult. To address these issues， this study develops the Medical Internet of data， a data infrastructure for medical clinical trials based on the Internet of data （IoD） technology. By encapsulating clinical trial-related data as digital objects and registering and publishing their unique persistent identifiers （PIDs） across the global network， the system ensures that clinical trial data can be uniquely verified and located. Using multi-dimensional and multi-granularity encryption access technologies based on trusted computing， the system guarantees the full discoverability and accessibility of clinical trial data. Furthermore， by exchanging identifiers to transfer data between different entities and systems， and recording the relationships between these identifiers， it enables full traceability and auditability of clinical trial data. The medical Internet of data has been explored in various scenarios and provides effective technical support for medical data integration and analysis， intelligent drug regulation， and collaborative medical services.

Key words: Medical clinical trials； , Internet of data； , data infrastructure； , Smart regulation