Mission 1, coordinated by the University of Pavia and the IRCCS Don Gnocchi Foundation, focuses on the pivotal task of clinical translation and innovation. Mission 1 aims to run extensive, in terms of number of patients and/or duration, mono- or multi-centric, clinical trials using healthcare robots or personal care robots that are currently available or will be adapted or developed by the consortium.

Mission 1 features 4 activities:

Activity 1 – needs of target individuals, aiming at understanding the current panorama of robotic rehabilitation in Italy and highlithing unmet needs and barriers of both patients and healthcare operators to robotics implementation; to this aim, specific surveys have been devised and disseminated, also through  the involvement of patients’ associations and scientific societies. Results of the surveys will inform the clinical trials development

Activity 2 – clinical protocols and trials, aiming at ensuring the smooth progress of the numerous clinical studies that will be promoted by the Initiative;to this aim, a trial monitoring tools will be used to early detect possible criticalities and take corrective actions on time. A statistics working group has been established to face statistical needs of the clinical studies such as sample size calculation

Activity 3 – health technology assessment, dedicated to defining and applying methodologies and running analyses for assessing the added value of rehab robotic solutions and allied technologies. This is done by: demonstrating – in a Health Technology Assessment (HTA) perspective (for technologies already or almost in the market) and in an early Health Technology Assessment (eHTA) perspective (for technologies with low TRL) - their acceptability and usability, effectiveness and organizational-economic sustainability; defining how to bridge them into the market; boosting their diffusion through the analysis of existing and potential market drivers and barriers and suggesting actions to overcome the detected obstacles; designing and supporting strategies for the promotion of a virtuous innovation ecosystem able to support the involved stakeholders in developing, adopting and using rehab robotic solutions.;

Activity 4 – legal, ethics and  policy acceleration, Activiity 4 coordinated by SSSA aims at framing the correct legal and ethical framework for the activities in the Initiative. It also aims to clarify the policy framework at various levels of governance. The research performed intends to pave the way to a smoother uptake of robotics technologies and allied technologies. To this end its scope reaches beyond the classical regulatory framework and connects it also with data laws, cybersecurity and legal design for a through mapping and development of the tools needed by the relevant stakeholders.

Irene Aprile
/ IRCCS Fondazione Don Gnocchi
Giovanni Comandè
/ Scuola Universitaria Superiore Sant’Anna
Silvana Quaglini
/ Università di Pavia
Giuseppe Turchetti
/ Scuola Universitaria Superiore Sant’Anna