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.