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Clinical trials with a decision issued after mid-August 2022 that have deferrals of any type in the application form are currently not published on CTIS. This is a temporary measure until the functionalities of the public portal are fully restored.
Currently, the website contains limited information on individual clinical trials since its launch on 31 January 2022. It will gradually contain more information as clinical trial sponsors and EU/EEA regulators use it to initiate and oversee clinical trials in the EU and EEA.
Starting from 31 January 2023, clinical trial sponsors need to apply to start a clinical trial via the Clinical Trials Information System, which is the system underpinning this website.
Information on individual clinical trials initiated in the European Union and the European Economic Area before 31 January 2022 can be found in the European Union Clinical Trials Register.
Information on clinical trials
A clinical trial is a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human participants (either patients or healthy volunteers).
You can view the information below on each clinical trial when available:
• EU clinical trial number
• Name and address of researcher or company carrying out the trial
• Outcome of the application and date of decision
• Start and end dates of the trial
• Start and end dates of participant recruitment
• Background information on the principal investigator
Further information is also available on trials, but its publication may be deferred to protect legitimate economic interests:
• Name of the trial
• Identity of the investigational medicine
• Trial design, therapeutic intent and protocol code
• Objectives and endpoints
• Participant inclusion and exclusion criteria
• Details of treatment arms
• Trial results
For more information on the basis for deferring publication, see: Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014”
Information may be redacted to protect the following:
- Personal data
- Commercially confidential information, in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest
- Confidential communication between EU/EEA regulators during the assessment
- Supervision of clinical trials by EU/EEA regulators
European Commission Reports
You can also find reports produced by the European Commission (Union Control reports) to verify that the Member States have supervised clinical trials in their jurisdiction in compliance with EU legislation.