On March 12, 2020, the Italian Medicines Agency (“AIFA”) has provided guidance on the management of clinical trials due to the COVID-19 emergency. The Guidance, which is addressed to CROs, Sponsors and non-profit organizations involved in clinical trials, allows for some derogations to support them face the criticalities. The Guidance is intended to ensure that activities related to clinical trials may still continue, despite the current situation.
The Guidance covers all the phases of clinical trials, i.e., submission of authorization requests of clinical trials; Ethics Committees’ evaluation; management of clinical trials outside investigational sites. The Guidance also provides some exemptions from the current EU and Italian legislation, i.e., management of the Investigational Medicinal Product; closure of a clinical trial site; clinical tests; clinical trial monitoring; reimbursement of exceptional expenses; possibility for Sponsors to enter into agreements directly with specialized agencies to carry out activities related to the management of patients. We provide further details below.
Submission of authorization requests of clinical trials
The Guidance provides for the postponement of submission of paper documentation and CD-ROM concerning authorization requests of clinical trials and substantial amendments. It also allows the submission of authorization requests by e-mail if the trials concern the treatment of Covid-19.
Ethics Committees’ evaluations of clinical trials/substantial amendments
Ethics Committees may arrange their meetings via web-conferences and other telematics ways.
Management of clinical trials outside investigational sites
The Guidance allows conducting clinical trial activities outside of investigational sites when this is necessary to limit the risk of coronavirus infection. In this case, Sponsors must notify a substantial amendment for immediate implementation to the competent Ethics Committee, outlining the urgency of the situation. Furthermore, Sponsors and CROs must prepare a risk evaluation plan and implement an action plan with the purpose to minimize contacts between patients and the staff, and to avoid to overload healthcare facilities.
As we mentioned above, the Guidance also provides some exemptions from the current EU and Italian legislation.
- Investigational Medicinal Product. Where possible, it may be useful to supply an amount of the Investigational Medicinal Product for a period of time longer than is normally estimated. Under these circumstances, deliveries of the medicinal product may be arranged directly to patients, upon indications of the director of the hospital pharmacy and the principal investigator.
- Closure of a clinical trial site. If a site is closed to the public for COVID-19 containment measures, it should be first assessed whether the clinical trial staff is able to guarantee the continuity of the trial. If it is not the case, the trial should be temporarily suspended or patients should be transferred to the nearest active clinical trial site.
- Clinical tests. Hematological tests should be carried out in public health facilities. However, private sites should be chosen only when it is the only possibility for patients’ protection.
- Clinical trial monitoring. Telephone contacts or videoconferences with the trial site staff are allowed provided that these are described in specific Standard Operating Procedures (“POS”) by the Sponsor/CRO and approved by the Data Protection Officer of the trial site.
- Exceptional expenses reimbursement. Sponsors are allowed to directly reimburse patients, in case they incur additional expenses for the implementation of urgent measures.
- Possibility for Sponsors to sign directly with specialized agencies to carry out activities related to the management of patients. Interestingly, in derogation from FAQ 11 of EMA’s “Q&A: Good clinical practice (GCP)”, Sponsors may enter into service agreements directly with specialized agencies or companies, g., home nursing services, to carry out activities related to the management of patients. Such activities must be carried out under the responsibility of the principal investigator.
AIFA makes clear that the Guidance remains valid until further notice.
Finally, it should be noted that on March 20, 2020, the European Medicines Agency published guidance on the management of clinical trials due to the current healthcare emergency. The EMA invites all the sponsors and investigators to consult the specific national legislation and guidance in place and to use them to complete the EMA’s guidance or, for specific matters, they make take priority over the EMA’s guidance.