New transparency rules for EU Clinical Trials System

The European Medicines Agency (EMA) has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The changes give access to clinical trial information to stakeholders including patients and healthcare professionals in a faster and more efficient way, according to the regulator.

The CTIS is the single-entry point in the EU for the submission and assessment of applications for clinical trials for sponsors and regulators. The system includes a public searchable database for healthcare professionals, patients and the general public to deliver the high level of transparency foreseen by the regulation.

The monthly number of submissions of clinical trials through CTIS continues to increase. Between late January 2022 and the end of August 2023, over 2,000 initial applications had been submitted through the system.

Balancing transparency with commercial confidentiality

One of the key revisions is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI). The updated rules strike a balance between transparency of information and protection of commercially confidential information, according to the EMA.

‘The [revised rules] benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early,’ the Agency said. ‘They also introduce process simplifications that benefit clinical trial sponsors who have to protect commercially confidential information and personal data.’

The changes are also designed to benefit healthcare professionals because the resulting system is more user-friendly, facilitating access to information about clinical trials and enrolment in clinical trials, and increasing awareness of possible treatment options.

The updates were triggered by feedback from stakeholders and an eight-week public consultation held between May and June 2023. The revised transparency rules will apply after their technical implementation in CTIS, including its public portal, which is expected to be finalised in the second quarter of 2024.