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Clinical Trials in Serbia Overview
Dr Ivan FerlezSenior Clinical Research Associate
OBJECTIVES
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
Recruitment rate Data quality 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 Logistic support
“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
Expirienced physicians highly motivated to participate in clinical trials
Lower costs of conducting clinical trials than in other European countries
PATIENT POPULATION
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
RECRUITMANT RATE Fast patient recruitment This is especially evident in
oncology, cardiology, rare diseases and pediatric clinical trials (increasingly difficult to conduct in Western countries because of considerable patient’s reluctance)
Evidence Based Data: sample fromPhase IIb CT
Serbia has the highest enrolling rate per CT
Successfully passed Sponsor internal audit in October 2008.
149All countries
8US
2Croatia
2Canada
1Spain
10Russia
1Hungary
4Lithuania
13Israel
7Italy
3Slovenia
14Poland
35Serbia
49Germany
No. of patientsCountry
Status on February 6, 2009:
SITE 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
High ethics standards and educational mission in
clinical trials
Quantified quality control in place
DISCIPLINED APPROACH
Source: MoH
Good clinical practice (ICH) and standard operating
Procedures.
ENGLISH LANGUAGE
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 Trial structure:
Phase I-5%
Phase II-25%
Phase III-50%
Phase IV-20% CT are mainly conducted in Oncology, Rheumatology and Diabetes
The medicine & Medical devices Agency of Serbia
REGULATORY REQUIREMENTS
EU directive is adopted GCP Inspection (local, EMEA & FDA) EC (for each site separately) prior to RA 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.
RA: meetings on a monthly bases (first Tuesday in a month); approval time 4 weeks starting from submission; Fee 1,400.00 EUR
EC: 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 Process
Documentation required: Investigator’s brochure (English) Signed protocol and amendments (English) Protocol Synopsis (Serbian) Informed consent form (Serbian) CRFs EC Approvals of participating centers Written consent of the Head of institution Investigational products documentation (GMP, CoA, Labelling –
translated) RA Investigator CVs 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 IMPD (RA)
Import license for study drug and lab kits issued with CT approval by RA
INFRASTRUCTION 4 Clinical Centres
• Largest comprehensive
Care Center• 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.
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