Registration and Results Reporting on Public Registries
Clinical study registries are public websites that have information about the research related to medicines. These websites are databases that allow the public and clinicians to review the wide variety of research that is being planned, ongoing, or finished.
By making this information available on public websites, UCB shares our research plans and results widely. By sharing, we make it possible for patients, caregivers, the public, clinicians, and researchers to explore data collected during the research process.
UCB currently registers and discloses results for clinical and observational studies on public websites including:
- EU Clinical Trials Register since 2004
- ClinicalTrials.gov since 2007 and including the Protocol and Statistical Analysis Plan (SAP) since 2018
- EU Register of Post-Authorisation Studies (EU PAS)
- UCB also follows all local registration and results reporting requirements
In November 2017, an independent third-party audited UCB’s registration and results reporting compliance on ClinicalTrials.gov. The audit found that UCB was highly compliant per FDAAA 801 and FDAAA 801 Final Rule. Review the audit results.
UCB’s Policy for Registration and Results Reporting is:
Studies that begin after
31 March 2020
UCB will register all Phase 1-4 interventional clinical studies in patients and healthy volunteers on EU Clinical Trial Register/Information System before the study starts
UCB will register all Phase 1-4 interventional clinical studies in patients on ClinicalTrials.gov before the study starts
UCB will register observational studies[1] on EU PAS or other public platform
UCB will submit results for all Phase 1-4 interventional clinical studies in patients and healthy volunteers on the EU Clinical Trial Register/Information System[2]
UCB will submit results for all Phase 1-4 interventional clinical studies in patients including Protocol and SAP on ClinicalTrials.gov[3]
UCB will submit results for observational studies[1] on EU PAS or other public platform
Studies that begin after application
of EU Clinical Trial Regulation
UCB will submit results for all Phase 1-4 interventional clinical studies in patients and healthy volunteers on EU Clinical Trial Information System and ClinicalTrials.gov
UCB will submit results for observational studies[1] on EU PAS or other public platform
The results of studies will be submitted:
Within 12 months after the study has ended, if the study included only participants 18 years old or older.
Within 6 months after the study has ended, if the study included any participants under 18 years old.
Results of observational studies[1] will be submitted within 18 months after the study ends.
Results of studies seeking deferrals[3], voluntary postings, and triggered studies will be submitted within 30 days of first marketing approval in EU or US.
[1] For this policy, observational studies refer to real-world evidence studies that compare the effectiveness or safety of two drugs (including at least one UCB product) using a hypothesis.
[2] Results of Phase 1 trials in adults not made public on EU Clinical Trial Register
[3] If the trial is studying an unapproved product or indication, in rare circumstances, a deferral may be requested