1. 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

2. 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

3. 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

4. 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

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

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