EU Survey on the Implementation of the Clinical Trial Regulation

From January 31, 2023, the Clinical Trials Information System (CTIS) has become mandatory for EU clinical trial applications under the CTR (Clinical Trials Regulation). However, there are still some issues regarding the functionality of the CTIS. Now, the European Commission (EC), together with the EMA and the HMA, published the results of a consultation on the implementation of the CTR. This consultation took place from July to September 2022 and represents the views of the stakeholders at the time of the consultation. The report notes that there is still a lack of harmonization at the level of national legislation and accompanying procedures in the Member States (MS). However, as the CTR leaves it to the member states to regulate individual details for implementation in many cases, it should come as no surprise that there are different interpretations and implementations of the CTR requirements in Europe. 

Survey Outcome

62 sponsors and other stakeholders provided their views on the new regulatory environment provided by the CTR and their experience with CTIS. Numerous technical and other issues are reported related to the use of CTIS, such as, for example, the following:

• Issues when answering to the request for information (RFI),
• No access to uploaded documents,
• Deferral request disappearing after submission, 
• Inability to update application,
• Difficulties due to the limitation to the harmonization of requirements,
• Specific and additional requirements from MS,
• Difficulties submitting and coordinating substantial modifications to different MS,
• Requirements for registration of clinical trial sites within the OMS and the lack of flexibility within the OMS,
• Different naming conventions in the MS for part I and part II documents.

Solutions have already been provided through a number of CTIS updates. According to the document, "a major CTIS release on 7 December provided major improvements, and other releases are planned until the end of January 2023 to correct blocking issues". Moreover, "new functionalities will be developed in 2023 and 2024, along with further user experience improvements, taking into account the views expressed by all users, sponsors, national authorities and ethics committees".

Transitional Trials

The CTR provides specific transition provisions for clinical trials that started under the CTD and that can be continued under the CTR. The regulation does not specify how sponsors shall continue the trials that are still ongoing once the transition period of the regulation comes to an end on 31 January 2025. Therefore, the Commission has addressed this topic in a Q&A document on the implementation of the CTR. It contains information on how sponsors can apply for an ongoing trial that has been authorized under the CTD by the national competent authority and approved by the ethics committee in the given MS. In addition, the EMA has published a sponsor handbook including advice on how to manage trials transitioned to the CTR in CTIS.   

For more information please see Clinical Trials: EU survey on the implementation of the Clinical Trial Regulation published on the European Commission´s Website.