Knowing which countries to submit clinical trial results summaries to is the easy part. What becomes difficult is learning the intricacies and transparency requirements of every clinical trial registry globally, including the European Union Clinical Trials Registry (EUCTR). Here is an overview of this registry:
Country: European Union
Year established: 2004
Points of interest:
- The EUCTR has been a primary registry of the World Health Organization’s Registry Network since September 2011, which includes protocol information on clinical trials conducted in the EU.
- This registry is the primary outlook to disclose clinical trials in the following countries: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.
- The EUCTR is part of EudraPharm, the community database of authorized medicinal products.
- All interventional clinical trials must adhere to protocol registration and results disclosure requirements.
- Disclosure of clinical trial results should be published within six months after study completion for pediatric clinical trials and 12 months after study completion for adult clinical trials.
- Studies in scope include:
- Phase 1 to Phase 4 adult clinical trials with at least one investigator site in the EEA
- Phase 1 to Phase 4 pediatric clinical trials with at least one investigator site in the EEA
- Clinical trials (pediatric and adult) that form part of an agreed PIP, whether conducted inside or outside the EEA
- Pediatric trials involving the use of a medicinal product covered by an EU marketing authorization and sponsored by the marketing authorization holder, whether or not included in an agreed pediatric investigation plan (PIP) and whether conducted inside or outside the EEA.
- Pediatric trials completed by 26 January 2007 covered by an EU marketing authorization (with a reduced set of data fields).
Related transparency research/articles:
- EMA scales back transparency initiatives because of workload
- WHO International Clinical Trials Registry Platform (ICTRP)
- EU trials tracker: who’s not sharing clinical trial results?
- Compliance with requirement to report results on the EUCTR: cohort study and web resource
- Many clinical trial status discrepancies identified between ClinicalTrials.gov and EUCTR
TrialAssure® Registry can automate the disclosure of clinical trial results for the European Clinical Trials Register (EUCTR). For questions or a free demo, contact us here.