New EU Clinical Trial Regulation and What it Means for Sponsors / LS Law

28th April 2022

On 31st January 2022, the new Clinical Trial Regulation 536/2014 (EU-CTR) came into force. Under the EU CTR, clinical trial applications for trials with medicinal products in humans can be submitted through a new Clinical Trial Information System (CTIS) along with amendments and other changes to ongoing clinical trials.

The new Regulation has been brought in to harmonise and simplify the processes for the application and supervision of clinical trials throughout the European Union (EU). Since 2004, the EU Clinical Trial Directive 2001/20/EC (EU-CTD) has governed the conduct of clinical trials in the EU. It attempted to standardise rules and had significantly enhanced patient protection in clinical trials. However, its real-life implementation created unintended challenges and as a directive, and the EU-CTD has not carried the same mandatory weight as a regulation, as it was left to the individual member states to decide how to implement the Directive, unlike a Regulation, which has direct enforceability in each EU member state.

Prior to the Regulation, clinical trial sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial. The new EU-CTR is binding on all EU member states in their entirety, this is a key difference from the EU-CTD as it seeks to increase transparency and restore the EU’s clinical research competitiveness by reducing administrative requisites and streamlining workflows. The hope is that it will help reinvigorate clinical research in Europe.

Benefits of EU-CTR for Sponsors

One Application

The Regulation enables sponsors to submit one online application via the CTIS for approval to run a clinical trial in several European countries, making it more efficient to carry out such multinational trials.

Efficiency

The Regulation makes it more efficient for EU Member States to evaluate and authorise such applications together, via the CTIS. The purpose is to foster innovation and research in the EU, facilitating the conduct of larger clinical trials in multiple EU Member States/EEA countries.

Improved sharing

The new Regulation will improve information-sharing and collective decision making on clinical trials and increase transparency of information on clinical trials. EU-CTR requires transparency throughout the development process. Protocols, for example, are subject to EU-CTR’s public disclosure rules. Sponsors will need to consider their options for deferring publication of specific details, including the study protocol, and the onus is on them to protect patient confidentiality at the point of submission. The new transparency rules intend to promote greater public awareness and understanding of clinical trials. To that end, summaries of trial results, including a layperson summary, must be submitted via the CTIS.

Safety

Another key benefit of the new system is its rigorous high standards of safety for all participants in EU clinical trials. EU-CTR requires all safety reporting via EudraVigilance. A single safety report can be submitted for trials involving more than one IMP, but all unexpected events which affect a trial’s benefit-risk balance must be reported within 15 days. Safety assessments also will be governed by separate legislation created by the European Commission.

Protection for Vulnerable Patients

EU-CTR substantively changes provisions for informed consent, including establishing more detailed guidelines at the EU level for: broad consent, simplified consent for cluster trials, consent for minors or incapacitated people, consent for pregnant or breastfeeding women, consent for other vulnerable populations and consent during trials in emergency settings.

Timeline of Regulation Implementation

Clinical trial sponsors can use the CTIS from 31 January 2022, but are not obliged to use it immediately, in line with a three-year transition period. However, from 31st January 2023, all new clinical trial applications in the EU must be submitted through CTIS. and from 31st January 2025 onwards, all clinical trials will be governed by the EU-CTR.

Key Takeaways of EU-CTR:

Enables sponsors to apply for clinical trial authorisation in up to 30 European countries with a single online application;
Allows national regulators to collaboratively process clinical trial applications in more than one country, request further information, authorise or refuse a trial and oversee an authorised trial;
Facilitates the expansion of trials to other EEA countries;
Enables transparency and access to information for any party interested in clinical trials conducted in the EEA through a searchable public website.

Our next blog will look at how the new Regulation affects the UK.

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New EU Clinical Trial Regulation and What it Means for Sponsors