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New European Clinical Trial Regulation: perception and expectations in Italy.
C Cagnazzo1, S Campora2, E Ferretti3
1Medical Oncology, Candiolo Cancer Institute, Candiolo.
Summary
Clinical Research Coordinators in Italy are more knowledgeable about the upcoming European Clinical Trial Regulation than investigators. Awareness and preparedness for the new regulation vary significantly between these groups.
Area of Science:
- Regulatory Science
- Clinical Trial Management
- Pharmaceutical Policy
Background:
- The European Clinical Trial Regulation (536/2014) aims to enhance patient safety and transparency in clinical trials, replacing the previous directive.
- Implementation of the regulation has been delayed, with an expected effective date of late 2018.
Purpose of the Study:
- To assess the awareness and perception of Italian Clinical Research Coordinators and Clinical Investigators regarding the new European Clinical Trial Regulation.
- To identify knowledge gaps and preparedness levels among clinical trial professionals in Italy.
Main Methods:
- An online survey was distributed to 190 Clinical Research Coordinators and 80 Clinical Investigators in Italy.
- The survey examined participants' understanding and views on the implications of the new regulation.
Main Results:
- Clinical Research Coordinators demonstrated higher awareness (84.4%) of the regulation compared to clinicians.
- While most investigators (74%) felt their sites were compliant, a majority of coordinators (65.2%) believed site staff lacked awareness of the changes.
Conclusions:
- The new regulation is anticipated to significantly impact all phases and types of clinical trial management.
- Fulfilling the regulation's requirements presents an opportunity for Italy to boost its pharmaceutical market attractiveness.
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