From 31 January 2023 onwards, all new clinical trials for investigative drugs in Europe will have to be registered on the new Clinical Trial Information System (CTIS), the Management Board of the European Medicines Agency has confirmed.
CTIS, which replaces the existing EudraCT registry, was originally hailed as a large step forward in clinical trial transparency, and was expected to facilitate the conduct of trials across national borders within Europe.
However, the registry's development and launch have been dogged by repeated delays and problems for many years. This in turn pushed back the date on which the related 2014 EU Clinical Trial Regulation would become fully applicable.
Now it's official: On 31 January 2023, a new chapter begins.
Is the new registry up to the job?
In early December, a coalition of major German industry and academic medical research associations called for the switch to the new registry to be suspended indefinitely, calling it "largely unmanageable for all parties involved".
However, European pharma lobby group EFPIA remained supportive of the planned launch date.
The summary of the Management Board's meeting initially paints a positive picture:
"The [European Medicines] Agency informed the Board that the system delivers the functionality required for new clinical trial applications which will continue to be developed and enhanced. The Board noted the progress towards further stabilisation of the system in preparation of compulsory use. This stabilisation will improve user experience."
"The Agency informed the Board about its delivery plan to ensure no blocking technical issues in the core processes by the legal deadline and its commitment to this plan."
"The Board welcomed the 2023 CTIS workplan which focusses on enhancing the user experience by implementing improvements in the most impactful functional areas of the system, future proofing and minimising risks to the technical core of CTIS."
However, it is clear that not all has being going to plan:
"As the initiation of this workplan is subject to the stabilisation of the system, the Agency committed to update the Board on a weekly basis on the progress towards stabilisation and full functionality of the system. This update will start on Friday 16 December and stakeholders will be kept regularly informed."
"The Agency informed the Board of the various potential risk scenarios and of the development of a business contingency plan."
It remains to be seen whether the new system will be able to cope with a surge in new trial applications.
Will trial protocols be kept hidden?
The Management Board also announced a review of a widely criticised plan by the European Medicines Agency to hide clinical trial protocols for up to five years after trial completion.
"The Board... agreed to review the current rules on disclosure of certain clinical trial documents and a review of CTIS [Clinical Trial Information System] transparency measures for 2023."
The Board had put the issue onto its agenda in response to a letter sent to it by eleven health groups including TranspariMED. The letter strongly criticised the plan to hide trial protocols, arguing that this would run counter to patient interests - and to European law.
More details on the planned 'review' are currently not available. According to EMA's press office, the full minutes of the Board's meeting will be made public on this webpage in late February.