The clinical trial activation process: a case study of an Italian public hospital.

ABSTRACT:

Background/aims

In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy).

Methods

A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the

SUBMITTER: Pelazza C 

PROVIDER: S-EPMC10998293 | biostudies-literature | 2024 Apr

REPOSITORIES: biostudies-literature