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Table 4 CASE MODEL 2: Example of protocols of EAP that follow a clinical trial and include patients who wish to continue the treatmentᅟ

From: Expanded Access Programme: looking for a common definition

Case model 2 Therapeutic area: Urogenital diseases

Clinical study design

Target

Endpoints

Italian or international

Phase

Multicentre, open-label, single-arm, early-access

Patients who have participated in the clinical trial and need prompt access to the results

Primary: assess the safety and tolerability in long-term treatment

Italy and other European countries

Phase 3

  1. In this case-model, patients included in the protocol have no comparable or satisfactory therapeutic alternatives but they have participated in the clinical trial and need to continue the treatment
  2. Considerations: despite the protocol target being coherent in Italy and in Europe with the EAP, the primary endpoint is typical of a clinical trial and the sponsor manages the protocol as if it were a clinical trial. In the USA this protocol would have be configured as an Open-label Extension study
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Trials

ISSN: 1745-6215