WP4: Clinical trials’ regulation, feasibility and dissemination

The objective of WP4 is to present and discuss the results and deliverables provided by every workpackage of the SMATCH project to the stakeholders (ANSM as regulatory authority, patient associations, experts in ethics, legal sponsors and clinical trials units) to assess acceptability and feasibility from the regulatory, ethical and operational perspectives. This will be done throughout the organization of 4 workshops with the stakeholders and extensive publications of our results.

1. Critically assess the specific regulatory modalities of the novel designs and methods proposed by WP1-WP3 along the regulatory process including the reporting
2. Critically assess the operational feasibility of the novel designs and methods proposed by WP1- WP3
3. Provide an ethical perspective on the novel designs and methods proposed by WP1-WP3
4. Disseminate the results of this PEPR axis