Clinical Research Around the World

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Presentation transcript:

Clinical Research Around the World Adrian Udrea MD PhD Medical oncologist Medisprof Clinic President of Romanian Association of Private Oncologists MAGI's Clinical Research Conference 2013 © 2013 Medisprof

HEALTH SYSTEM IN ROMANIA/ REGULATORY 1 National reimbursement agency/NO private reimbursement NO complete covering for lab, ana-path, radiology or treatments Romanian Ministry of Health-sites clinical trials authorization Sponsors/CRO -National drugs agency/ National ethics comitee Romania= 5-10 sites>10 years experience/Romanian private oncology association= 4 sites FDA/EMA/sponsors audits/ high quality reliably data 2 MAGI's Clinical Research Conference 2013 © 2013 Medisprof

PATIENTS 5% SCREENING FAILURES due to unaccepted ( not signed) informed consent (including PPFE and lab samples for genetic studies) CLINICAL TRIAL=complete covering for all facilities and treatement in a 80% population that has a 300 euros medium income/month 90 % patients COMPLIANCE with protocols: Personal financial reasons Unaccepted toxicities 3 MAGI's Clinical Research Conference 2013 © 2013 Medisprof

OUR TEAM CLINICAL TRIALS 24-48 hours - feasibility questions 1 PI, 5 subINVESTIGATORS medical oncologists, 2 Study coordinators, 2 PHARMACISTS, 4 STUDY NURSES 24-48 hours - feasibility questions Local start-up documents-CV's, GCP/IATA on site 48-72 hours fully executed contracts SOP/ISO 9001/2008 quality standard procedures on site 4 MAGI's Clinical Research Conference 2013 © 2013 Medisprof

WHY ONCOLOGY CLINICAL TRIALS IN ROMANIA ? 5 MAGI's Clinical Research Conference 2013 © 2013 Medisprof

Thank you! Adrian Udrea MD PhD MAGI's Clinical Research Conference 2013 © 2013 Medisprof