Department of Biomedicine Is there a future for Swiss Academic Clinical Research? 5th Symposium of the Swiss Clinical Trial Organisation 18 June 2014, Bern Brigitte Meier Head of Section Human Research and Ethics
Department of Biomedicine New Human Research Act: A first appraisal In force since January 1 st 2014 Art. 118b Cst. Human Research Act (HRA) KlinV Ordinance on clinical trials Therapeu?c products Transplanta?on Human Research Ordinance (HFV) Sampling/collec?on Further use Organisa?on Ordinance on the Human Research Act (OV- HFG) Ethics commikees Coordina?on office e.g. surgery, psychology, care Deaths, foetuses, embryos 2
Public Health Directorate The main changes I Ø Extended scope Ø Distinct separation of competencies between ethics committees and Swissmedic Ø Submission to ethics committees and Swissmedic (if necessary) in parallel Ø Obligation to register clinical trials Ø Multi-centre studies (lead ethics committee) 3
Department of Biomedicine The main changes II Ø (Risk-based) Categorisation of all studies with persons Ø Requirements adapted to intervention type and category Approval procedure Reporting of adverse events Trial insurance Ø Reporting of adverse events in non-drug studies (and observational studies) 4
Public Health Directorate Effects 5 ethics committees with university hospitals 4 ethics committees with cantonal hospitals (>150 studies/year) Last revised 1 May 2014 / slide prov. by Ethics Committee of Bern 5
Public Health Directorate Vision 2013 Registry WHO Primary Registry Registry clinicaltrials.gov Studienportal.non-ch Registry functions Search functions Clinicaltrialsportal.gov Registry functions Search functions register search Suppl. database Swiss National Clinical Trial Portal test Applicant (sponsor/investigator) Submission of application Search functions Authorities (EC/Swissmedic/FOPH) get information Interested members of the public 6
Vision / Reality 2014 ZH Evidence Federal Department of Home Affairs FDHA Department of Biomedicine Cantons Interface GE VD Applicant Swiss Confedera?on BASEC EKNZ BE TG SNCTP search portal VS TI SG The public 7
First experiences with HFG Federal Department of Home Affairs FDHA Public Health Directorate Ø Multi-centre research projects: Lead committee procedure -> room for improvement Ø Risk categorisation: Approval procedures, insurance, reporting requirements graded according to hazard potential -> no statement possible to date Ø Ethics committees are more professional and processes more harmonised -> level of knowledge not yet the same with all ethics committees 8
Public Health Directorate What comes next? Various activities are planned: Ø Improving information on all web pages, including improvement of the clinical trial search portal (SNCTP) Ø Ø Ø Ø 2 advisory groups including stakeholders Continue exchange sessions with competent authorities (ethics committees and Swissmedic) Knowledge transfer btw CA and other courses Monitoring of implementation and evaluation of the Human Research Act (HRA) Ø HRA conference early 2015 9
Department of Biomedicine Thank you for your attention 10