[3-B-2-03] Clinical Trial Readiness Initiative and FDA Standards Roadmap
Despite advancements in the conduct of trials the regulatory submission of clinical trial data has not significantly changed in the past decade. Innovations in modelling, AI, real-world evidence, synthetic data, and technology have the potential to revolutionize clinical trial processes but, regulatory agencies continue to require sponsors to fit this wealth of data into outdated formats that were never designed to accommodate such extensive information.
The FDA are actively reviewing data standards to facilitate, simplify, and reduce the regulatory burden on sponsors and clinical trialists by engaging with HL7’s FHIR standard, focusing on several key projects: modernizing the standard product label (SPL), refining the Pharmaceutical Quality - Chemistry Manufacturing and Controls (PQ/CMC) standard, and enhancing Risk Evaluation and Mitigation Strategies (REMS). Streamlining the process of data validation, increasing data specificity, and for REMS, streamlining validation of a healthcare providers' ability to prescribe.
Adopting modern standards will yield multiple benefits for Health Authorities (HAs) and sponsors. A shared and harmonized data model will simplify the submission process, enabling sponsors to submit a single package to multiple HAs. FHIR will facilitate sharing of clinical data sets between HAs and sponsors, creating trusted cloud environments where large data sets can be evaluated. Also HAs will be able to link related data more easily through FHIR’s shared data model, enhancing collaboration and efficiency in the regulatory process.
The FDA are actively reviewing data standards to facilitate, simplify, and reduce the regulatory burden on sponsors and clinical trialists by engaging with HL7’s FHIR standard, focusing on several key projects: modernizing the standard product label (SPL), refining the Pharmaceutical Quality - Chemistry Manufacturing and Controls (PQ/CMC) standard, and enhancing Risk Evaluation and Mitigation Strategies (REMS). Streamlining the process of data validation, increasing data specificity, and for REMS, streamlining validation of a healthcare providers' ability to prescribe.
Adopting modern standards will yield multiple benefits for Health Authorities (HAs) and sponsors. A shared and harmonized data model will simplify the submission process, enabling sponsors to submit a single package to multiple HAs. FHIR will facilitate sharing of clinical data sets between HAs and sponsors, creating trusted cloud environments where large data sets can be evaluated. Also HAs will be able to link related data more easily through FHIR’s shared data model, enhancing collaboration and efficiency in the regulatory process.