Transforming the European Landscape of Clinical Trial Submissions

The protocol has been drafted, approved by the sponsor, and it is time to submit for approval to competent authorities and ethics committees.

Showtime!

Unless there is a regulatory department that manages the submissions and approvals of the clinical study documents, this task falls to the clinical research associate (CRA). Each local CRA will review the requirements of the local competent authority and local ethics committees – yes, plural – in their European country.

Once each submission package is prepared with its 10 to 20 documents, the CRA will master each of the submission portals that the competent authority and ethics committees use. Luckily, there are less and less authorities that request paper submissions, although there are still some that do.

Both the competent authority and each ethics committee will come back with queries that the CRA will have to respond to and resolve. Some, if you are lucky enough, are just duplicates from their peer ethics committees which will make the answer easier and more efficient. But of course, if each region within a country has a different ethics committee with specific requirements, think of the differences between European countries... Yes, plenty.

Time to Harmonize

This isolation in the submission process of clinical trials resulted in not just an immense workload for the CRAs or regulatory departments at a sponsor or CRO, but also in a lack of harmonization between authorities within a country. There is also a lack of transparency and communication between the authorities of different European countries.

That is why the Clinical Trials Regulation entered into application on January 31, 2022 to carry out clinical research on a large scale, with high standards of public transparency and safety for clinical trial participants. On the same day, the new Clinical Trial Regulation overruled the previous Clinical Trials Directive (EC) No. 2001/20/EC, which until now regulated clinical trials in the EU Member States.

Sponsors can now submit one single clinical study application through the Clinical Trials Information System (CTIS) to be approved in multiple European countries. Yes, as simple as that! From the sponsor perspective, it brings efficiency into carrying out multinational trials at the same time as it facilitates the EU Member States to evaluate and authorize these clinical trials together.

This change, of course, comes with a transition period. Since its implementation last January, sponsors could choose if they preferred to submit their applications through CTIS or under the previous directive. However, starting this month (January 31, 2023), sponsors will need to use CTIS to apply to start a new clinical trial in the EU. The final transition date will be January 31, 2025 at which time all trials submitted under the previous directive will have to be recorded on CTIS.

Reducing Burden Through Unity

The new Clinical Trials Information System not only transforms the clinical trial application landscape into one of transparency, unity and shared information but also alleviates the burden on the sponsor and study teams who until now, had to submit and manage each of the applications separately for each European country.

Maria Milas

Industry Expert & Former CRA

Guest

Maria is a former CRA passionate about the plight of clinical research site staff. She is also the founder at CRA Connect, a safe online space where Clinical Research Associates connect, ask questions, share knowledge and have a voice