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.

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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:

Registration for studies that begin after 16 March 2026

  • UCB will register all Phase 1-4 interventional clinical studies on public registries (eg, Clinical Trial Information System (CTIS), ClinicalTrials.gov, and local registries) to the extent required by legal obligations and commitments to external guidelines.
  • UCB will register noninterventional Post-Authorization Safety Studies (PASS) that are imposed (Category 1 and Category 2 PASS) and voluntary noninterventional PASS included in the Ris Management Plan (Category 3 PASS), on the Heads of Medicines Agencies (HMA)-European Medicines Agency (EMA) Catalogue of Real World Data (RWD) studies prior to study start.
  • UCB will register primary data collection (PDC) and secondary data use (SDU) RWE studies that are not subject to noninterventional  PASS requirements on local registries or on a preferred registry in line with applicable legal obligations.

Results Reporting for studies that begin after 16 March 2026

  • UCB will submit results of all Phase 1 studies in Healthy Volunteers and Phase 1 studies in Patients on Clinical Trial Information System [CTIS] and any other locally required registry according to legal obligations and commitments to external guidelines.
  • UCB will submit results of Phase 1 studies in Patients on a publicly accessible webpage in accordance with the IFPMA commitment, within one year of study completion, provided that any reasons for confidentiality no longer apply.
  • UCB will submit results of Phase 2-4 Studies on CTIS, Clinicaltrials.gov, and any other locally required registry according to legal obligations and commitments to external guidelines.
  • UCB will submit results of category 1-3 PASS on the HMA-EMA Catalogue of RWD studies.
  • UCB will submit results of PDC and SDU RWE studies that are not subject to noninterventional PASS requirements, on local registries or on a preferred registry in line with the applicable legal obligations.
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The results of studies will be submitted:

  • Within 12 months of study completion if the study included only participants 18 years or older on CTIS
  • Within 6 months of study completion if the study included any participants under 18 years on CTIS
  • Within 12 months of the Primary Outcome Last Patient Last Visit (POLPLV) on ClinicalTrials.gov
  • Within 12 months after study completion on HMA-EMA Catalogue of RWD studies for Category 1-3 noninterventional PASS
  • For studies seeking deferrals[1], voluntary postings, and triggered studies, results will be submitted within 30 days of first marketing approval in the EU or US.

[1] If the trial is studying an unapproved product and/or indication a deferral may be requested