WP7 Engagement with regulatory groups, agencies and other stakeholders

WP7 takes care of three aspects of PRISM’s structure and outreach: (1) Ethical requirements for the work undertaken by PRISM; (2) the impact of PRISM outcomes from the patient`s perspective; and (3) initiate the regulatory path for clinical readouts identified by PRISM. Many clinical trials in brain disorders have focused on primary outcomes that are marginally relevant to the affected person´s quality of life (e.g. 20% reduction on a general psychopathology scale in SZ). The lack of ecological and pragmatic outcomes that translate to real-world advantages in many trials may be due to a lack of involvement of the individuals affected by the diseases, the patients themselves and their families. Involvement of such stakeholders is a key component of this WP. In addition, WP7 will liaise with regulatory agents to pave the regulatory path for clinical readouts relevant to acute social withdrawal as well as attention, working memory and sensory processing deficits across various disease conditions. Clinical trial use of primary outcomes based on biomarkers across different disorders is considered an innovative development methodology that will require scientific advice from EMA for future qualification of novel methodologies for medicine development.