Clinical Trials In Serbia If March 2009Presentation Transcript
Clinical Trials in Serbia Overview Dr Ivan Ferlez Senior Clinical Research Associate
To present Serbia as a potential country for future CTs
To help understand opportunities and benefits of conducting CTs in Serbia
KEY ISSUES IN CT
Experienced and well trained clinical trial staff
Local presence of internationally experienced CROs
Time to obtain import license
Time to obtain regulatory approvals
Suitable technical & medical infrastructure
“ There has never been a better time to conduct clinical research in Serbia , as the country has undeniably become one of the most popular destinations in this ever competitive field” Applied Clinical Trials, April 2006.
WHY SERBIA ?
Fast study start-up due to simplified, time-saving regulatory procedure
Fast patient recruitment due to the large population living in the major cities
E xpirienced physi c ians high ly motivat ed to participate in clinical trials
Lower costs of conducting clinical trials than in other European countries
There are over 7.5 million inhabitants in Serbia , with 2 million living in Belgrade, the capital city
Large patient population is easily accessible-high recruitment rates can be achieved
Access to a large pool of untreated & treatment naïve patients
Patients are motivated to participate in clinical trials-compliance & follow-up during long-term studies are excellent
Fast patient recruitment
This is especially evident in oncology, cardiology, rare disease s and pediatric clinical trials ( increasingly difficult to conduct in Western countries because of considerable patient ’s reluctance )
Evidence Based Data: sample from Phase IIb CT
Serbia has the highest enrolling rate per CT
Successfully passed Sponsor internal audit in October 2008.
Status on February 6, 2009 : 149 All countries 8 US 2 Croatia 2 Canada 1 Spain 10 Russia 1 Hungary 4 Lithuania 13 Israel 7 Italy 3 Slovenia 14 Poland 35 Serbia 49 Germany No. of patients Country
S ITE STAFF
Serbian providers offer high standards, competitive cost and superb recruitment rate
“ Study staff and monitors are, invariably physicians. The combination of highly educated professionals makes it possible to conduct very complex scientific protocols. This results in adherent to study schedules, significantly fewer protocol deviations and lower screen failure drop out rate.
” Applied Clinical trials, 2004, Vol 13, No1
Educated and experienced physicians are highly motivated to participate in CTs
400 physicians GCP-certified so far
DISCIPLINED APPROACH Source: MoH High ethics standards and educational mission in clinical trials Quantified quality control in place Good clinical practice (ICH) and standard operating Procedures .
Serbia has the highest percentage of English language speakers in southeastern and central Europe
Investment Guide—Serbia , 2nd Edition, May 2005, Bank Austria Creditanstalt
NUMBER OF INITIATED CTs
During 2008. 130 CTs were initiated
CT are mainly conducted in Oncology, Rheumatology and Diabetes
The medicine & Medical devices Agency of Serbia
EU directive is adopted
GCP Inspection (local, EMEA & FDA)
EC (for each site separately) prior to R A approval needed
EC approvals necessary for RA submission ; EC-approved centre can start the study upon RA approval ; Approval of additional centres is just administration.
meetings on a monthly bases (first Tuesday in a month) ;
approval time 4 weeks starting from submission ; Fee 1,400.00 EUR
organized by most of the big hospitals, accoding to ICH-GCP; No central EC.
meetings on a monthly bases or ad hoc .
approval time 4 – 6 weeks; Fee: up to 800.00 EUR
AVERAGE SET UP TIME IS 3 MONTHS
The medicine & Medical devices Agency of Serbia
REGULATORY REQUIREMENTS EC and RA Approval P rocess
Documentation required :
Investigator’s brochure (English)
Signed protocol and amendments (English)
Protocol Synopsis (Serbian)
Informed consent form (Serbian)
EC Approval s of participating centers
Written consent of the Head of institution
Investigational products documentation (GMP, CoA, Labelling – translated) RA
Local insurance policy
Other information for patients (i.e. patient card in Serbian)
Registration status (list of countries) – if registered
At least one EU country where the same CT is approved
Other documents, if needed
Import license for study drug and lab kits issued with CT approval by RA
4 Clinical Centres
Tertiary care emphasis
High patient numbers across all localizations
400 GCPcertified professionals
Source: IORS Clinical Centre Nis , Niš Clinical Centre Serbia, Belgrade Clinical Centre Vojvodina, Novi Sad Clinical Centre Kragujevac , Kragujevac
Welcome to Serbia “ Over the past few years, Serbia has made a great step forward aiming to enrol grater number of clinical trials of high quality, high scientific and ethical standards for the ultimate benefit of the patients. … With above in mind, we welcome Sponsor and CRO companies to consider a more intensive cooperation with Serbia in the field of clinical trials.” DDS , Ivan Ferlez Senior Clinical Research Associate March , 2009.