Oracle Expert on RWD Integration Challenges and Solutions in Clinical Trials
Oracle exec on clinical trials infrastructure in 2025 and beyond
Oracle discussed the development of clinical trials infrastructure utilizing FHIR-based APIs.
Summary
An Oracle Health & Life Sciences expert discusses the technical and regulatory hurdles of integrating Real World Data (RWD) into clinical trials. Success requires leveraging standards like FHIR and CDISC to balance patient privacy protection with scientific advancement.
Key Players
Details
According to an Oracle Health & Life Sciences expert, key challenges in incorporating RWD into clinical trials include data quality standardization (from diverse sources like EHRs and registries) and technical interoperability issues. Modern solutions such as those utilizing CDISC standards, FHIR-based APIs, and hybrid data models are proving effective. On the regulatory front, compliance with international privacy laws (like GDPR and HIPAA) and implementing dynamic consent management systems that respect patient data ownership are crucial. To ensure reliability, organizations should adopt blockchain-based audit trails and automated quality assurance programs. Overcoming these challenges requires proactive engagement with regulatory authorities to establish Real World Evidence guidance and forming strategic partnerships. This forms the foundation for future clinical trials that integrate research and care systems.
Technology Note
FHIR（Fast Healthcare Interoperability Resources）は医療データ交換の国際標準。このエントリの関連技術: FHIR
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