EMA announces revised transparency rules for the EU Clinical Trials Information System (CTIS)
The Clinical Trial Regulation (EU) No 536/2014 (CTR) came into effect in the EU in January 2022 with, among other aims, the intention of increasing the transparency of clinical trial activity in the region.
The aim of increasing transparency was to allow the public to access information on clinical trials being conducted in the EU, in particular, for patients to be able to utilise the provided information to make informed decisions regarding participation in a trial. It would also allow access to the results of a clinical trial in which they were involved thereby putting the patient at the forefront of clinical research.
To achieve this, an EU wide submission portal and database was introduced, namely CTIS (Clinical Trials Information System). CTIS acts as both a single entry-point for the submission of clinical trial data and as a clinical trial database providing the public access to the relevant data.
In accordance with Article 81(4) of the CTR, documents and data in CTIS should be publicly accessible unless exceptions relating to the protection of personal data and commercially confidential information (CCI) apply. Therefore, all trial documents should be publicly accessible in CTIS, with the exception of quality related documents, financial arrangements and some supervision related information. To aid the protection of CCI, a deferral mechanism was put in place to allow sponsors to delay the publication of certain trial-related information and documents for up to 7 years after the end of the trial.
The transparency rules and criteria adopted by European Medicines Agency (EMA) are provided in the Appendix, on disclosure Rules to the Functional specifications for the EU portal and EU database to be audited – EMA/42176/2014. However, the application of these has proven to be overly complicated and burdensome with the requirement to redact many documents and also leading to problems with the functionality of CTIS for individuals.
Following on from a public consultation to garner feedback on the transparency rules, the EMA have announced that they have adopted revised transparency rules for the publication of clinical trial information. The revised rules will instead focus on the early publication of clinical trial data and documents that are most relevant to the public, thereby improving the user experience within CTIS.
The revised rules mean that the mechanism for deferral of publication of documents has been removed, in combination with reducing the number of documents that are published, to simplify the process and aiming ‘to guarantee access to clinical trial information in a faster and more efficient way’. Whilst documents will still need to be redacted to protect personal data and CCI, the documents that will be publicly available will be limited to those that will have direct impact on the patient (i.e., protocol and related patient facing documents, informed consent form and patient information sheet, and recruitment arrangements).
To facilitate the revised rules, an update to CTIS is required which is envisaged to take place by the 2nd quarter of 2024, however, the exact date is yet to be communicated and in the interim the deferral mechanism detailed in the EMA guidance will remain in place.
How can S-cubed help you?
We can prepare and coordinate all the necessary regulatory documentation you may require for a clinical trial in the EU, including IMPDs and IBs, (ensuring these meet the requirements of the CTR). We can also support the submission and management of a clinical trial application within the EU through CTIS.
Any Questions?
If you have any questions on this topic, please don’t hesitate to ask. You can contact via email (info@s-cubed-global.com), and telephone (S-cubed Ltd: +44 1235 77 22 60).