The EU’s new CTIS is Just ten days away: ready?

The conduct and oversight of clinical trials in the EU will undergo a radical transformation when the new Clinical Trial Information System (CTIS) goes live on January 31^st, paving the way for the long-awaited Clinical Trial Regulation (No 536/2014) to take effect.

The default setting in CTIS is to make public almost all the data and documents submitted as part of a clinical trial application– except commercially confidential and personal information – at the first opportunity unless a deferral is agreed.

In practical terms, this means that when sponsors are creating a new clinical trial application in CTIS, they will have to submit two versions of most documents, such as the trial protocol, the investigator brochure and the safety and efficacy sections of the Investigational Medicinal Product Dossier (IMPD), according to the EMA.

One version will be “for publication” to the general public and should not contain any personal data. The other “not for publication” version will only be visible to regulators and can include names and signatures or other personal information, if needed, to support the trial’s evaluation.

The only documents that will never be made public are those relating to quality (and their assessment) and financial arrangements between investigators and trial sites.

Companies planning a strategy to balance transparency requirements with business interests will need to start early as many critical decisions will have to be made at the time of submitting the initial application, such as:

• uploading both “for publication” and “not for publication” versions of clinical trial documents together.
• exercising the option to delay the release of documents meant “for publication” as well as certain structured data submitted to CTIS (e.g., trial title, trial design, therapeutic intent) on justified grounds.

All such deferral requests will be reviewed by concerned member states, who may ask for more information. The deferral timelines will depend on the trial category, with a maximum period of up to seven years after the end of the trial in the EU/EEA allowed for category 1 trials. (See Table below.)