Table 5.

CASE MODEL 3: Example of clinical trial who is presented as EAPsᅟ

Case model 3 Therapeutic area: Viral diseases
Clinical study design	Target	Endpoints	Italian or international	Phase
Multicentre, open-label, single-arm, early-access	Patients with chronic hepatitis C, acute fibrosis and cirrhosis	Primary: make possible early use of the drug for patients who cannot participate in the clinical trial	International	Phase 3
	Patients with similar features to those in the clinical trial but unable to participate because the trial is closed or the trial site is not geographically accessible, or because not eligible under ongoing trial protocols	Secondary: assess the safety and tolerability of the treatment

In this case-model, patients included in the protocol have no comparable or satisfactory therapeutic alternative and they cannot participate in the clinical trial

Considerations: since the purpose of the protocol is to make possible early use of the drug for patients who have no comparable or satisfactory therapeutic alternative and cannot participate in the clinical trial, this protocol can come under Ministerial Decree 8 May 2003 [14], as a CUP [11] and EAP [21]. However, the study is managed like a clinical trial, and the cost of the add-on therapy is charged to the centre where the trial takes place