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Table 5 CASE MODEL 3: Example of clinical trial who is presented as EAPsᅟ

From: Expanded Access Programme: looking for a common definition

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

  1. In this case-model, patients included in the protocol have no comparable or satisfactory therapeutic alternative and they cannot participate in the clinical trial
  2. 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