Clinical Trials
Clinical trials are interventional studies that test the effect of an intervention on human participants. This perspective covers the data standards for regulatory submissions, the registration and results-reporting requirements, and the platforms for sharing individual patient data after trial completion.
Standards
CDISC is the data standard the FDA (Food and Drug Administration) has required since 2016 for new drug, biologics, and abbreviated new drug applications (NDAs, BLAs, ANDAs). This does not extend to all clinical trials: investigator-initiated and academic trials that never result in such an application fall outside the requirement. The European Medicines Agency has not mandated CDISC, though it accepts and encourages its use. CDISC also forms the data infrastructure for interventional research conducted through ECRIN and NeurATRIS. IHE profiles define the choreography for how HL7 FHIR, DICOM, and related standards are applied together in clinical interoperability implementations, and serve as the de facto technical compliance layer for EHDS. The OHDSI Clinical Trials Working Group is developing conventions for converting CDISC SDTM data into OMOP CDM, enabling trial data to be analysed alongside real-world observational data using OHDSI tooling.
Trial registration
Registration of clinical trials before first patient enrolment is a legal requirement in most jurisdictions. ClinicalTrials.gov is the primary global registry. The CTIS (EU Clinical Trials Information System) is the mandatory registration and results reporting platform for interventional trials of medicinal products under EU clinical trials legislation. It does not cover medical device trials, governed separately under the EU Medical Device Regulation. Observational studies also fall outside CTIS. Unlike interventional trials, they have no equivalent EU-wide regulation and are instead governed by national law and ethics committees, which vary by country, alongside GDPR. The exception is Post-Authorisation Safety Studies mandated by a regulator as a condition of marketing authorisation, which register in the HMA-EMA Catalogues of real-world studies under EMA’s pharmacovigilance oversight.
Data sharing after completion
Individual patient data from completed trials can be shared via controlled-access platforms. VIVLI is an international platform for clinical trial data sharing, providing a secure analysis environment with governance infrastructure for data access agreements. The YODA Project (Yale Open Data Access) is an independent third-party platform focused on pharmaceutical trial data sharing. From March 2031, the EHDS secondary-use framework adds a mandatory route alongside these voluntary platforms: national Health Data Access Bodies must make clinical trial data available for research and policy purposes beyond the original trial.
Notable examples
EPINOV was a French national multicentre randomised controlled trial (RCT, 2018–2023, 356 patients, 12 centres) testing whether personalised whole-brain simulation using SEEG (stereoelectroencephalography) data could improve epilepsy surgery outcomes. Funded by ANR under PIA3 and registered on ClinicalTrials.gov (NCT03643016), it deposited an open dataset of 30 personalised virtual brain models on EBRAINS following trial completion. Virtual Brain Twin, its direct successor, is an active Horizon Europe initiative expanding the same personalised brain modelling approach to psychiatric conditions through EBRAINS infrastructure.
For the clinical data models and interoperability standards that govern trial data exchange and secondary use, see Health. For trial registration and data management planning as standalone topics, see Study Registration and Data Management.