Updated transparency rules for EU clinical trials - the end of the deferral mechanism

Current regime

So far, the publication of documents and information on clinical trials is mainly regulated by a document by the EMA from 2015 called Appendix, on disclosure rules, to the “Functional specifications for the EU portal and EU database to be audited - EMA/42176/2014” (s. here). To secure the protection of personal data and especially commercially confidential information (CCI), as laid down in Art. 81 (4) of the CTR, sponsors can apply redactions to the document versions for publication and/or use the deferral mechanism, delaying the publication of some information or documents (e.g., main characteristics of the trial, protocol, subject information sheet) for a certain period. The potential deferral period depends on the category of the respective clinical trial, which is mainly based on the phase of a clinical trial.

Removal of the deferral mechanism

The revised transparency rules completely remove the deferral mechanism for clinical trials of all categories. Thus, all documents as well as information entered into structured data fields (fields populated by the user in CTIS, either free text fields or fields which predefined values to choose) will be published at the time defined in the revised CTIS transparency rules. The amount of published information and the timing will still depend on the category of the respective clinical trial. Below, we have exemplarily compared the different timelines for the publication of a clinical trial protocol under the current regime and under the revised transparency rules.

Publication of a clinical trial protocol

Category 1

Current situation: Time of decision on the trial. Potential deferral up to the time of MA using this trial or up to 7 years after the end of the trial.

Revised transparency rules: Paediatric population: Together with the final summary of results, as soon as the results are submitted in CTIS.
Adult population: 30 months after the end of the trial in the EU/EEA.

Category 2

Current situation: Time of decision on the trial. Potential deferral up to the time of MA using this trial or up to 5 years after the end of the trial.

Revised transparency rules: Time of decision on the trial.

Category 3

Current situation: Time of decision on the trial. Potential deferral up to the time when the summary of results is made public (usually 12 months after the end of the trial).

Revised transparency rules: Time of decision on the trial.

Further changes

Generally, the revised CTIS transparency rules aim to make the system less complex, more efficient and user-friendly.

In return for the removal of the deferral mechanism, the EMA states that the amount of documents/ information published at all will be reduced to those relevant for the public, patients and researchers in the EU/EEA, leading to a reduced workload for users engaged in the necessary redactions. For example, the subject information sheet and the informed consent form in case of a category 1 clinical trial will not be published at all, while under the current regime the documents are published at the time of decision on the trial with a deferral option up to the time of MA or up to 7 years after the end of the trial.

Furthermore, the revised timelines will partly lead to later publication dates, though without the option for a further deferral. For instance, the protocol of category 1 clinical trials will be published at a later date under the revised CTIS transparency rules but without the option for a further deferral (see above). This will bring a higher level of legal certainty for sponsors.

Outlook

The EMA plans to implement the new rules by the second quarter of 2024, however, the exact timing will depend on the progress of the technical implementation in CTIS.

The removal of the deferral mechanism will lead to significant changes for clinical trial sponsors in their strategies to protect CCI. While sponsors to date make use of the interplay between deferrals and redactions to protect their data (see our blogpost here), the removal of the deferral mechanism will require them to change their strategy to effectively protect CCI. We assume that there might be an increased need for the redaction of CCI in documents for publication. A particular focus should be put on the information to be provided via structured data fields in CTIS, which cannot be redacted, as there will be no more possibility to defer the publication of this information.

There are still several open questions, including the implications to already granted deferrals, which will have to be clarified by further guidance or Q&A documents.