In March 2026, the European Commission published updated guidance on the Clinical Trials Regulation, introducing practical changes to improve how clinical trials are conducted across Europe.

Clinical trials in the EU are organised by “sponsors” (pharmaceutical companies, universities, hospitals or research organisations) responsible for designing, funding and running a trial.

Under the Regulation, sponsors must submit applications in two parts: Part I (scientific aspects) and Part II (national requirements, such as ethics approvals and trial sites).

Article 11 of the Regulation allows sponsors to submit Part I first and complete Part II later in some countries, with the intention to make multinational trials easier.

This is useful because sponsors are often not ready to provide all country-specific information at the same time. For example, they may not yet have finalised trial sites, investigators or ethics approvals in every country, even though the scientific design of the trial is already complete.

In reality, the EU’s Clinical Trials Information System (CTIS) created a bottleneck. When some countries only received Part I, sponsors were unable to submit important updates to the trial or expand the trial to additional countries until all countries had completed Part II.

This meant that a single country with incomplete national documentation could hold up the entire trial, delaying its progress or forcing sponsors to withdraw and resubmit applications. As a result, sponsors were often discouraged from including certain countries, especially smaller ones, from the outset.

The new guidance introduces an interpretation of Article 11 (the “Article 11 workaround”) to unblock this process.

In simple terms, sponsors can now include all countries from the start, even if some are not yet ready with full national paperwork. For those countries, they submit basic placeholder information instead of full Part II details. Later, sponsors complete the missing national information before the trial can start in that country. This approach should help avoid delays in setting up and updating multinational trials.

Crucially, patient safety is not affected as no trial can begin or recruit patients in a country until all national requirements are assessed and approved.

This matters a great deal to patients as access to clinical trials in Europe is deeply unequal. Patients in smaller countries have far fewer opportunities to participate.

This has real consequences:

• Delayed or no access to innovative treatments

• Fewer options for patients with advanced cancers

• Widening survival gaps across Europe

For digestive cancer patients, clinical trials are an important pathway to innovative treatments, especially in advanced or hard-to-treat cancers. For many, a clinical trial may be their only treatment option.

However, while welcome, this is a practical workaround. To truly deliver for patients, the EU must fix CTIS in the long term, reduce administrative burden (particularly for academic trials) and actively address geographic inequalities in access to clinical trials.

Europe must ensure that its research ecosystem delivers what matters most: equal access to clinical trials and to life-saving innovation for all patients, regardless of where they live.

Author:

Filip Karan