Challenges of performing clinical trials in Malta

Abstract

Introduction: Trials performed in small communities like Malta pose challenges due to the number of participants and facilities. In the European Union, the guidelines which came into effect in January 2022, outline requirements including the use of CITS, which is a system that must be used to upload all documentation needed for a clinical trial. The setting up of a user friendly platform accessible to stakeholders so as to support them in meeting the regulatory requirements, may encourage conduction of trials in small states.

Aims: • To investigate impact of the new EU regulations for clinical trials • To create a template for clinical trial planning • To outline steps involved in setting up clinical trials • To identify tools and personnel, possible sources of funds, premises, and facilities where trials could be conducted. Objective: • To develop a template that serves as a platform which outlines procedures and obligations required so as to support interested entities.