EU proposes new rules for clinical trials

As of January 31, the evaluation and monitoring processes for clinical trials began to be harmonized throughout the EU, especially through the Clinical Trials Information System, managed by the European Medicines Agency. On this date, the Clinical Trials Regulation will enter into force, which will improve the way clinical trials are conducted in the EU, ensuring the highest levels of safety for participants and greater transparency of trial information.

What changes is the Regulation bringing to clinical trials in the EU?

• A streamlined application procedure for all clinical trials conducted in Europe via an online portal (the “Clinical Trials Information System” or CTIS)
• A single authorisation procedure for all clinical trials, to allow a fast and thorough assessment by all concerned EU countries
• The extension of the silent agreement principle⁽¹⁾ to the authorisation process giving more legal certainty to the organisations or individuals that undertake clinical trials
• Transparency of clinical trial data will become the rule. Information on the approval, execution and result of a given clinical trial will be available for the general public.
• Improvement of the collaboration between Member States on the assessment of unexpected events occurring in clinical trials, thus assuring the highest standards of safety for participants in European clinical trials. Ultimately, this will lead to an even better understanding of the benefits and the risks of authorised medicinal products.

How will the Regulation ensure a greater level of harmonisation?

For each clinical trial submitted in CTIS, one Reporting Member State will lead the assessment process for those elements of the clinical trial application that are common throughout the EU (“part I of the assessment report”).

Each Member State in which the trial will be run has the possibility to provide objections to the Reporting Member State on the common elements in the application (“part I”), and is in charge of the assessment of the elements with a more local or ethical component (“part II”).

In the end, each Member State takes its own decision based on the outcome of the part I and II assessment.

Each Member State needs to define the responsibilities of the National Competent Authority and ethics committee.

The assessment and exchanges between Member States are bound to strict timelines during which objections need to be formulated and resolved.

When will patients fully benefit from this Regulation?

The CTR contains several measures to ensure the continuity of clinical research, some of which enter into force immediately, whilst others will take a few years to full effect.

The impact on patients will be on different levels.

First, there is the level of the authorisation of clinical trials. For the coming year, organisations are able to choose between submitting under the CTR or submitting under the old rules.

From 31 January 2023 onward, all new submissions will need to follow the CTR rules.

It is expected that this will lead to more multinational trials, especially in smaller Member States.

Second, ongoing clinical trials that have been authorised according to the old rules can continue until 31 January 2025. If a trial would still be ongoing by that time, it needs to be resubmitted according to the CTR rules, and all CTR principles will apply. For patients in these trials, there are no changes or interruptions of the treatment.

Thirdly, the new reporting and transparency rules apply only for CTR rules.

Information on authorised trials will be immediately public, allowing patients to verify which trials are ongoing in which Member States.

In the longer term, the information and results of all CTR trials will be available.

Source

European Commission

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Background

The European Commission is building a strong European Health Union, in which all EU countries prepare and respond together to health crises, medical supplies are available, affordable and innovative, and countries work together to improve prevention, treatment and aftercare for diseases such as cancer. The European Health Union will

• better protect the health of our citizens
• equip the EU and its Member States to better prevent and address future pandemics
• improve resilience of Europe’s health systems

Its main initiatives include crisis preparedness and response measures; the launch of a new European Health Emergency Preparedness and Response Authority (HERA) to develop, produce and procure medical countermeasures before and during a health crisis; its pharmaceutical strategy to modernize the regulatory framework and support research and technologies that reach patients; and finally its Europe’s Beating Cancer Plan, which aims to prevent cancer and ensure that patients, survivors, their families and caregivers can enjoy a high quality of life.

Source

European Commission

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