Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation

Area of Science:

• Clinical research
• Regulatory science
• Pharmacovigilance

Background:

• The European Clinical Trial Regulation (CTR) was implemented on January 31, 2022, marking a significant advancement for clinical research in Europe.
• The French National Agency for Medicines and Health Products Safety (ANSM) began preparations for the CTR's application in 2017.
• Monitoring clinical trial opportunities is crucial for patient access to innovation and sponsor attractiveness.

Purpose of the Study:

• To share key aspects of France's preparation for the European Clinical Trial Regulation.
• To discuss shared indicators for monitoring clinical trial opportunities.
• To propose new criteria for evaluating the CTR's implementation.

Main Methods:

• Analysis of preparatory actions undertaken by the French National Agency for Medicines and Health Products Safety (ANSM) since 2017.
• Identification and discussion of shared indicators for assessing clinical trial landscapes.
• Proposal of novel metrics, specifically focusing on the time from authorization request to first patient inclusion.

Main Results:

• The ANSM's proactive preparation since 2017 has been instrumental in adapting to the new European Clinical Trial Regulation.
• Shared indicators are essential for evaluating a territory's capacity to foster clinical research and innovation.
• The time from the initial authorization request to the first patient enrollment is a key performance indicator for assessing CTR implementation.

Conclusions:

• The European Clinical Trial Regulation represents a substantial opportunity to enhance clinical research across Europe.
• Effective monitoring through relevant indicators is vital for optimizing clinical trial processes and outcomes.
• New performance metrics, such as the time to first inclusion, can effectively gauge the success of the European Clinical Trial Regulation.