The EU Clinical Trials Regulation (CTR) 536/2014 came into force in 2014. It replaced the Clinical Trials Directive (CTD) 2001/20/EU, which aims to improve patient safety and harmonize clinical trial rules across Europe. However, the CTR may result in start-up delays in Belgium. This study investigates the impact of the CTR on study start-up teams and ethics committees in Belgium.

This study used a web-based survey to collect data from two groups of respondents: members of study start-up teams within contract research organizations (CROs) and members of ethics committees recognized under the law of May 7th, 2017. Survey questions were designed using input from experts and were pretested for validity and reliability. The study provides insights into potential barriers and opportunities for improving the study start-up process in Belgium.

The survey gathered responses from study start-up teams and ethics committees. Results showed no statistically significant difference between the two legislations in the time taken for dossier submission for phase I and phase II-IV studies and ethics review for phase I studies. However, phase II-IV studies take longer under the CTR to be reviewed by ethics committees than under the CTD. Challenges, opportunities and suggestions were collected and will be discussed.

Program:

• 12h30: Introduction 
• 12h35: The impact of the EU Clinical Trial Regulation on study start-up teams and ethics committees in Belgium: research and results by Yousra El Gazari
• 13h15: Critical reflection and Q&A