Perspectives from Karlien Lubberink and the clinical research community

It has been a year since the implementation of the Clinical Trials Information System (CTIS) became mandatory for all initial clinical trial applications in the EU.

We reached out to Karlien Lubberink, Clinical Research Professional, to gather her insights and experiences. “As with any new system, there is a learning curve involved. I firmly believe that with time and experience, the process will become smoother. We’re currently in a transitional phase, I’m confident that within a few years we’ll proudly say that Europe has an excellent assessment system.”

Navigating the transition

Karlien highlighted several challenges encountered during this transition period:

Extended timelines
While the idea behind the new system is to strengthen Europe’s clinical trial infrastructure by aligning and streamlining timelines across the region, Karlien noted that timelines in e.g. Belgium and the Netherlands are currently longer than before, for initial approvals but mainly for approval of substantial modifications.

Lack of automatic notifications
Unfortunately, there are no automatic notifications within CTIS, which can make staying updated on the progress of the assessments more challenging.

Transitioning studies from CTD to CTR
Before an ‘old’ study can be transitioned to CTIS, the protocol should be one consolidated or harmonised version. This might require an adjustment which needs to be approved in all European countries under CTD, adding an extra layer of complexity to the process.

Coordination challenges
While CTIS allows for a single submission for multi-national studies, certain submissions cannot be done in parallel, requiring meticulous coordination among stakeholders. Additionally, adding a new European country to a transitional study requires requesting a Part I Assessment Report from the reporting member state, which delays the process.

Despite these challenges, Karlien also highlighted important positive aspects of CTIS:

Unified management
The centralized nature of CTIS offers increased oversight. Especially with multi-national studies, having a single Research Dossier Part I in CTIS provides better visibility and control, facilitating easier central management of study documents and submissions. Moreover, this approach ultimately leads to cost reduction.

New transparency rules
Documents that require public accessibility undergo a dual uploading process: once for authorities and another for the public (redacted). Thanks to the new transparency rules, a significantly reduced number of documents within CTIS are made public, resulting in considerable time savings.

As we continue to adapt to the new system, it’s essential to address these challenges and capitalise on the opportunities it presents. This need was acknowledged at the EUCROF24 conference in Prague, where we could attend dedicated sessions focused on CTIS.

We appreciate Karlien sharing her experiences, and we’re eager to hear from others in the community about their experiences with CTIS. If you have any insights or stories to share, please reach out.