CTIS applies for Clinical Trials Regulation (CTR) and Clinical Trials Directive (CTD)
As we have previously outlined, the CTIS is the centralized EU online portal and database for regulatory submissions, authorizations, and supervision of clinical trials across the EU/European Economic Area (EEA). The CTIS, which is used by regulators and sponsors, is the gateway for submissions and assessments of applications for clinical trials in the EU. The CTIS also features a publicly accessible area that may be used by patients and health care professionals: the public portal. The CTIS is used for applications of clinical trials under the Clinical Trials Regulation (CTR), which entered into force on 31 January 2022, and for clinical trials authorized under its predecessor governance the Clinical Trials Directive (CTD), and which are expected to continue beyond 30 January 2025. As of 31 January 2025, all ongoing clinical trials need to be transitioned to the CTR and the CTIS, for which we have also given pointers here.
Legal basis for submission of data and information and its publication
The CTR provides the legal basis for a “single entry point” where data and information relating to clinical trials is submitted, known as the “EU portal”. Data and information submitted through this EU portal is stored in the publicly accessible1 “EU database”.2 The CTIS includes both the EU portal and the EU database. Certain pieces of data should not be published, such as personal data and commercially confidential information (CCI).3 The updated rules aim at better balancing the need for transparency and the protection of CCI.
Key changes in the revised rules
Key documents of interest
Under the revised rules, the number of documents to be published is reduced to certain key documents of interest. These are documents that are deemed to have more impact for patients and clinical researchers. The type of documentation that have to be published as well as the timing of publication is based on the type of clinical trial (e.g. Phase 0 – Phase IV) and population age. Documents that are published will be redacted by sponsors in order to protect, e.g., personal information and commercially confidential information (CCI).
Structured data fields
Also part of the revised rules is the introduction of “structured data fields” to be filled in by users of CTIS directly. The structured data field either allow to freely enter certain text or to choose from fixed values. Such fields contain relevant information for the public, especially patients and clinical researchers. However, structured data fields, unlike documents to be submitted to CTIS, cannot be redacted. Sponsors should therefore refrain from including any personal data or CCI in the structured data fields. Information to be found in structured data fields concerns, e.g., the trial title, study design, inclusion and exclusion criteria, clinical investigator sites in EU member states, as well as sponsor’s contact details.
In addition, a few days before the launch of the revised portal, it was announced that - as a temporary measure - the publication of the strength fields in the product section has been suspended. The suspension is a result of ongoing discussions regarding commercial confidentiality of these data fields. The type of information and timing of publication depend, similar as for the key documents of interest, on the classification of the clinical trial.
Deferral mechanism
Another major change is the abolishment of the deferral mechanism. Under the prior transparency rules, sponsors could opt for a deferral in order to postpone the publication of certain data and documents for up to seven years after the end of the clinical trial to protect personal data and CCI. In practice, the deferral mechanism appeared to be complicated due to information management and data security reasons. As the deferral mechanism is removed publication of key documents, such as protocols, happens at an earlier stage. Under the Revised CTIS Transparency Rules, redaction is the only method to protect personal data and CCI.
What is next?
The new version of the public part of CTIS shows data and documents of clinical trial applications submitted on or after 18 June 2024, in accordance with the revised CTIS transparency rules. It is yet to be seen what will happen with the temporary measure involving the suspension of the publication of the strength fields. It has also been announced that new features will be added to the CTIS public portal over the next few months to improve the overall usability of the system, such as advanced search. Updates from EMA on both the temporary measure and improvement of the system will follow in due course.
Sponsors of clinical trials in the EU should be aware that clinical trial information may become publicly available earlier than before. In order to protect CCI and personal data, they should carefully redact documents that will be published through the EMA’s CTIS.
References
1 Article 81 sub 4 CTR.
2 Article 80 CTR.
3 Article 81 sub 4 CTR.
