Italian Medicines Agency provides clarifications in relation to the introduction of decentralised elements in clinical trials

The Italian Medicines Agency (AIFA) published in late August its "Guideline on regulatory simplification and decentralised elements for conducting clinical trials of medicinal products in accordance with regulation (EU) no 536/2014".

The scope of this guideline, which confirms full applicability in Italy of relevant EU recommendation/guidelines, concerns organisational aspects. It provides some clarification, applicable at domestic level only, with regard to the introduction of decentralised elements in clinical trials that are (already) provided for by EU regulations/guidelines or that are not expressly prohibited.

The adoption of the guideline is mainly aimed at providing broader information to investigational sites and ethic committees which, in some cases, are a bit reluctant to embrace decentralised clinical trials (DCT), including the use of service providers. 

Outline of the new guideline 

The following are the topics discussed in the guideline:

• use of third-party service providers;
• reimbursement of expenses for participants in clinical trials;
• compensation for loss of earnings for participants in clinical trials;
• delivery of the investigational medical product (IMP) to the participants' homes;
• allocation of costs for IMP and auxiliary medicinal product (AxMP);
• clinical trials in out-of-hospital settings.
   

In general, AIFA's position does not differentiate from the December 2022 EU Recommendation Paper. 

Guidance for service providers

With respect to service providers, AIFA points out that:

• It is recommended to prioritise the use of the resources of the investigational sites. However, they are allowed to use service providers made available by the sponsor and/or even contracted directly by the investigational site.
• The principal investigator, who retains ultimate responsibility for all medical decisions concerning the conduct of the trial, has the power to express an opinion on the service provider and decide whether or not it is (or its operation is) adequate in the context of the conduct of the clinical trial.
• The service provider must be adequately trained on the study protocol, including data privacy requirements and obligations.
• Once the data controller has been identified (either the sponsor or the investigational site, as the case may be, depending on the kind of outsourced activity) the service provider (as data processor) must provide the data controller with sufficient guarantees to implement appropriate technical and organisational measures in order to comply with the GDPR. Appropriate contracts must in place among the parties.
• The tasks and responsibilities of the service provider must be clearly indicated in its contract with the sponsor, as well as in the contract between the sponsor and the investigational site.  The powers, duties (including data protection roles) and responsibilities of the principal investigator in the relationship with this third party should also be specified in these contracts.
• To this end, investigational sites should put in place organisational measures to ensure that the principal investigator is informed well in advance of the content of the draft contract between the sponsor and the healthcare facility, with particular reference to the involvement of a service provider.

Osborne Clarke comment

The guideline does not introduce novelties from an Italian regulatory perspective while its focus is more to define what investigational sites should do to permit the principal investigator(s) to always remain in control of the clinical trial.