The European Medicines Agency (EMA) has revised its transparency rules on publishing information about clinical trials submitted through the Clinical Trials Information System (CTIS). EMA aims to expedite access to trial information to stakeholders including patients and healthcare professionals (HCPs).

The revised rules will apply after their technical implementation in CTIS. EMA will also launch a public portal, which should be finalised in Q2 2024. The users of CTIS will be alerted before the new rules become applicable.

The revision of transparency rules was triggered by the feedback provided by stakeholders on their experiences after the launch of CTIS. EMA held an eight-week public consultation between May and June 2023.

To increase transparency, EMA removed the deferral mechanism, which allowed sponsors to delay certain data and document publication for up to seven years after the end of their trial. The delay in publishing these documents was meant to protect personal data and commercially confidential information (CCI).

According to EMA, the revised rules strike a balance between transparency and protection of CCI. Patients will be able to flag the most relevant trials for them and be notified when the information is published earlier, whereas HCPs will be able to access information about enrolment and increase awareness of new treatment options.

What is in the new rules?

EMA classified trials into three categories. The first category covers pharmaceutical development clinical trials such as Phase 0 and Phase I, bioequivalence and bioavailability trials, biosimilar product similarity studies, and equivalence trials for combination products.

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The second category includes therapeutic exploratory and confirmatory trials such as Phase I/II, Phase II and Phase III trials. The third category covers therapeutic use clinical trials like Phase III/IV, Phase IV and low interventional clinical trials. Additionally, all categories are split into paediatric and adult populations.

In Annex I of the revised rules, EMA outlines the timing of information publication for each category and patient population. For example, study protocols and synopsis for second and third category trials must be published at the same time the study is approved. However, this information for first-category paediatric trials can be published together with the final summary of results, while first-category adult trials will have 30 months after the trial has ended.

EMA launched CTIS in January 2022 to streamline clinical trial application (CTA). At the time, the old portal EudraCT was still active and sponsors could submit their new CTAs, but the old system closed its doors to new trials in January 2023. Sponsors can still manage their ongoing trials via EudraCT, but it will officially close in January 2025. Then, all new and ongoing trials will have to be managed on CTIS.