Challenges of performing clinical trials in Malta

Abstract

Trials performed in small countries like Malta pose challenges due to small participant sampling sizes and limited facilities. This study investigates the impact of the new EU regulations, brought into effect in January 2022, on clinical trials in Malta, and proposes a template for clinical trial planning, to guide in the steps involved in setting up clinical trials. The new EU guidelines include the use of CTIS; a system that must be used to upload all documentation needed for a clinical trial. A validated questionnaire was disseminated amongst 50 healthcare professionals to identify challenges in performing clinical trials in Malta. Three specialist doctors from Mater Dei Hospital, involved in 3 different types of clinical trials, were interviewed to obtain an insight into hurdles encountered. Qualitative interviews with the national economic development agency were conducted to explore the prospect of formulating a national strategy to attract and support investment and operations in clinical trials. Meetings were held with private pharmaceutical companies and private clinics to determine their interest to participate A challenge highlighted was that of putting together a skilled team of professionals. Other challenges identified were availability of funding and the willingness of people to participate. The private pharmaceutical companies contacted did not show any interest in being part of the set-up of clinical trials. The setting up of an “ecosystem” as the basis on which all local clinical trials are conducted would be beneficial, to avoid having each trial being conducted in isolation. Such a formal ecosystem reflecting prior experience and best-practice would increase the ease with which trials are conducted. The ecosystem would identify the tools and personnel required, possible sources of funds, premises, and facilities where the trials could be conducted, facilitating the process. A template Standard Operating Procedure was compiled, with the intention of facilitating the setting up of clinical trials, and to provide step-by-step guidance. This includes registering with the Malta Medicines Authority; getting together a team of healthcare professionals; finding premises and laboratory services even if not part of the national health services; and recruiting volunteers, amongst other aspects.