The Italian Medicines Agency (AIFA) has released a guideline addressing regulatory simplification and decentralized elements for conducting clinical trials of medicinal products, in accordance with Regulation (EU) No. 536/2014. This guideline aims to clarify organizational aspects and promote the adoption of decentralized clinical trials (DCTs) within Italy, while adhering to EU regulations and guidelines.
Focus on Decentralized Elements
The AIFA guideline focuses on providing detailed information to investigational sites and ethics committees, some of which have been hesitant to fully embrace DCTs. It addresses several key aspects, including the use of service providers, reimbursement of expenses for trial participants, compensation for loss of earnings, delivery of investigational medicinal products (IMPs) to participants' homes, allocation of costs for IMPs and auxiliary medicinal products (AxMPs), and clinical trials conducted in out-of-hospital settings.
Guidance on Service Providers
AIFA's guideline provides specific instructions regarding the use of service providers in clinical trials. It recommends prioritizing the use of resources within investigational sites but acknowledges the potential need for external service providers contracted by the sponsor or the site itself. The principal investigator retains ultimate responsibility for all medical decisions and has the authority to evaluate the adequacy of the service provider. Service providers must be adequately trained on the study protocol, including data privacy requirements. Clear contracts must outline the tasks and responsibilities of the service provider, as well as the roles and responsibilities of the principal investigator in relation to the third party. Investigational sites should ensure that the principal investigator is informed well in advance about the contract between the sponsor and the healthcare facility, especially concerning the involvement of a service provider.
Alignment with EU Standards
In general, AIFA's position aligns with the December 2022 EU Recommendation Paper, ensuring consistency in the application of decentralized trial elements across Europe. The guideline seeks to regulate in detail those organizational aspects for which there was a lack of clear references at the national level, with the aim of ensuring that the provisions contained or not expressly prohibited in EU standards and guidelines are correctly applied in Italy.
