Countdown: Time pressure for sponsors to move trials to the CTR
Xandra Neuberger
Associate Director Regulatory Affairs and international service lead for clinical trial applications at PharmaLex
Abstract
Time is fast running out for transition of ongoing clinical trials in the EU to the Clinical Trial Regulation and submission through the Clinical Trial Information System (CTIS).
The article will explore the challenges and implications for clinical trials that have yet to transition to the CTR. It will delve into key steps and strategic planning to manage the transition and address amendments to existing trials.
Strategic planning is key with time running out for transition to CTR
In a recent monthly newsflash, the European Medicines Agency again pointed out how little time remains to transition ongoing clinical trials in the EU to the new framework of the Clinical Trials Regulation (CTR) (1) from the Clinical Trials Directive (2). The agency recently estimated that only around 580 of the 5,000 trials to be transitioned to the CTR had done so (3), which raises the possibility of a rush at the end of the transition period.
The risk is that any trial that doesn’t have approval under Regulation (EU) No 536/2014 – “the CTR” – will lose its legal basis after 30 January 2025. This time crunch will put a lot of strain on EMA technical support and member state capacities to provide adequate technical and content-related support.
For sponsors, the challenge is to ensure they are proficient in the Clinical Trial Information System (CTIS) (4) and well-versed in requirements for the transition in order to be able to submit a well-prepared transition application early enough so as to not risk their trials lapsing. A ...
