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MD clinical trials, profit clinical trial contract released

With a note published on their institutional website, the Italian Medicine Agency informed that the contract was defined for the performance of profit clinical trials on medical devices, in compliance with the provisions of article 2, comma 6, Law no. 3/2018.

The document – in Italian and English – was released by the National Coordination Centre of the Ethics Committees for clinical trials on medicines for human use and medical devices, a body that ensures procedure harmonisation and compliance with the deadlines, carrying out tasks such as the coordination and monitoring of the activities for the assessing of the ethical aspects of clinical trial on medicinal products for human use and medical devices.

The model of contract proposed is a sort of guide, that can be useful to hospitals and sponsors to harmonise the terms and agreement to carry out clinical trials. These are minimal contents. In case of special trial designs or specific needs, the contract can be either integrated or used in its current form, ensuring the harmonisation of its application, such as in case of multicentre studies. At the moment, the use of the model of contract is not mandatory, therefore contracts already negotiated or those close to be signed shall not be amended and the bodies can continue to draft their own model.

The release of the contract has occurred during a transitory phase for medical devices, when the reference regulation is still Directive 93/42. However, as of May 2021 the new European Regulation EU 2017/745 will be implemented, providing for stricter provisions to obtain and maintain the CE marking. With the final implementation of the Regulation, an increased need of clinical trials is expected, and the definition of a univocal contract can actually contribute to the harmonisation of the process for the application to perform clinical trials, giving Ethics Committees, hospitals and sponsors a useful tool to harmonise approval process and the start of new research projects, preventing delays and bureaucracy.

Written by: Sofia Tabacco

Foto di Michal Jarmoluk da Pixabay