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Clinical Research in Turkey
        prepared by Miacheal Morgan
               Kuantum 2008
Turkey: The Potential for Clinical Trials
The potential for conducting           The goal is to have 40,000
Clinical trials in Turkey is           people working in this area by
enormous. There are 94                 the year 2010. The annual
universities, 59 medical schools,      budget reserved for clinical
1190 hospitals, 200,000 hospital       trials by the pharmaceutical
beds. 95,100 medical doctors are in    companies in Turkey was 27.5
practice and 46% are specialized. If   million dollars in 2005.
we look at the number and
distribution of Research and
Development personnel, they can
be broken down as follows:
37% technological sciences,
19% maths, physics, life science
14% medical sciences,
11% agriculture
The Increasing Interest

In the last ten years, the
                                This increase has
number of physicians who
                                necessitated the
wish to conduct a clinical
                                pharmaceutical companies to
trial has increased, mainly
                                outsource their load. At
due to an increase in the
                                present, there are around 15
awareness of the
                                CROs in Turkey, working
importance of clinical trials
                                mainly for the pharmaceutical
and the increasing interest
                                companies.
of pharmaceutical
companies.
Clinical Trials 1997-2006
400
300
200
100
  0
   1997 1999 2001 2003 2005
clinical trials   other trials   total number of trials
Clinical Research- Important Advantages

Growing Population
With a expanding population of 74
million and a developing
infrastructure, Turkey is a promising
plateau for clinical research. The EU
integration process will provide a
better future for clinical drug trials
and the GCP education programs will
increase the number of qualified
clinical researchers and ethical
committee members.




                                         Rate of Population Growth between the
                                         years 1961 - 2001
Untapped market
                        During the last 25 years the liberal economic policies
                        of several governments have opened the Turkish
                        markets to foreign investors and the clinical research
                        is no exception. The current estimate that drug trials
                        comprise around 10 million dollars in activity for
                        Turkey annually is still considered to be quite low
                        compared to many European countries, but the
                        gradually increasing number of trials is expected to
                        have a significant impact in medical, scientific and
                        economic progress.


Well established medical and regulatory infrastructure

Important advantages that Turkey offers are the
presence of well- equipped and high level university
and state hospitals, well-trained specialized clinicians:
lower costs associated with ethical reviews, regulatory
approvals and investigator compensation, and a good
success rate for patient recruitment.
Phase Clinical Trials in
       Phase Clinical Trials in
          Turkey 1997-2006
           Turkey 1997-2006
250
 250
200                           Phase I
 200                           Phase I
150                           Phase II
 150                           Phase II
                              Phase III
100                            Phase III
 100                          Phase IV
                               Phase IV
 50                           Total
  50                           Total
  0
   0
        7
    98 8
        9
    00 0
        1
    02 2
   2003 3
    04 4
   2005 5
    06 6
 1919 9
 19 9
 1919 9
 20 0
 2020 0
 20 0
 2020 0
 20 0
 2020 0
 20 0
   1997


   2909


   2001
Approval of
                                    Approval of
Preparation of                        Local
 Preparation of                        Local
Local Dossier                        Ethics
 Local Dossier                         Ethics
                                   Committees
                                    Committees



                                                  Submission to
                  Submission to                    Submission to
                   Submission to                    Ministry of                          Submission for
                   Local Ethic                       Ministry of                          Submission for
                     Local Ethic                      Health                             Import License
                    Committee                          Health                             Import License
                     Committee




                                                                   Approval by Ministry of
                                                                    Approval by Ministry of
                                                                          Health
                                                                           Health




                     Timelines for study approvals
                     Timelines for study approvals


                                      1               1                                        2
 2 weeks           2 weeks           week            week               2 months              days
The Advantage of a Local CRO partner

Local CROs, and international organizations with a strong local presence, can
provide an answer to the challenges of emerging markets.
As the clinical trial markets in these countries grow, the number of CROs with local
knowledge is also increasing.


                                             A local CRO can understand the Turkish
                                              A local CRO can understand the Turkish
                                             market, how ititfunctions and the most
                                              market, how functions and the most
                                             expedient ways to solve problems.
                                              expedient ways to solve problems.




A local CRO can understand how to reduce costs and
 A local CRO can understand how to reduce costs and
save time when conducting aastudy in Turkey
 save time when conducting study in Turkey
“While many U.S- and European-based pharma / biotech
companies are looking for novel sites for clinical trials,
Turkey, with her increasing number of medical schools
and highly specialized trained clinicians and scientists, is
becoming even more attractive as an investment and
professional site for clinical trials.”

                                 Clinical Scientific Research Potentials
                                 in Turkey 2007

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Cr In Turkey

  • 1. Clinical Research in Turkey prepared by Miacheal Morgan Kuantum 2008
  • 2. Turkey: The Potential for Clinical Trials The potential for conducting The goal is to have 40,000 Clinical trials in Turkey is people working in this area by enormous. There are 94 the year 2010. The annual universities, 59 medical schools, budget reserved for clinical 1190 hospitals, 200,000 hospital trials by the pharmaceutical beds. 95,100 medical doctors are in companies in Turkey was 27.5 practice and 46% are specialized. If million dollars in 2005. we look at the number and distribution of Research and Development personnel, they can be broken down as follows: 37% technological sciences, 19% maths, physics, life science 14% medical sciences, 11% agriculture
  • 3. The Increasing Interest In the last ten years, the This increase has number of physicians who necessitated the wish to conduct a clinical pharmaceutical companies to trial has increased, mainly outsource their load. At due to an increase in the present, there are around 15 awareness of the CROs in Turkey, working importance of clinical trials mainly for the pharmaceutical and the increasing interest companies. of pharmaceutical companies.
  • 4. Clinical Trials 1997-2006 400 300 200 100 0 1997 1999 2001 2003 2005 clinical trials other trials total number of trials
  • 5. Clinical Research- Important Advantages Growing Population With a expanding population of 74 million and a developing infrastructure, Turkey is a promising plateau for clinical research. The EU integration process will provide a better future for clinical drug trials and the GCP education programs will increase the number of qualified clinical researchers and ethical committee members. Rate of Population Growth between the years 1961 - 2001
  • 6. Untapped market During the last 25 years the liberal economic policies of several governments have opened the Turkish markets to foreign investors and the clinical research is no exception. The current estimate that drug trials comprise around 10 million dollars in activity for Turkey annually is still considered to be quite low compared to many European countries, but the gradually increasing number of trials is expected to have a significant impact in medical, scientific and economic progress. Well established medical and regulatory infrastructure Important advantages that Turkey offers are the presence of well- equipped and high level university and state hospitals, well-trained specialized clinicians: lower costs associated with ethical reviews, regulatory approvals and investigator compensation, and a good success rate for patient recruitment.
  • 7. Phase Clinical Trials in Phase Clinical Trials in Turkey 1997-2006 Turkey 1997-2006 250 250 200 Phase I 200 Phase I 150 Phase II 150 Phase II Phase III 100 Phase III 100 Phase IV Phase IV 50 Total 50 Total 0 0 7 98 8 9 00 0 1 02 2 2003 3 04 4 2005 5 06 6 1919 9 19 9 1919 9 20 0 2020 0 20 0 2020 0 20 0 2020 0 20 0 1997 2909 2001
  • 8. Approval of Approval of Preparation of Local Preparation of Local Local Dossier Ethics Local Dossier Ethics Committees Committees Submission to Submission to Submission to Submission to Ministry of Submission for Local Ethic Ministry of Submission for Local Ethic Health Import License Committee Health Import License Committee Approval by Ministry of Approval by Ministry of Health Health Timelines for study approvals Timelines for study approvals 1 1 2 2 weeks 2 weeks week week 2 months days
  • 9. The Advantage of a Local CRO partner Local CROs, and international organizations with a strong local presence, can provide an answer to the challenges of emerging markets. As the clinical trial markets in these countries grow, the number of CROs with local knowledge is also increasing. A local CRO can understand the Turkish A local CRO can understand the Turkish market, how ititfunctions and the most market, how functions and the most expedient ways to solve problems. expedient ways to solve problems. A local CRO can understand how to reduce costs and A local CRO can understand how to reduce costs and save time when conducting aastudy in Turkey save time when conducting study in Turkey
  • 10. “While many U.S- and European-based pharma / biotech companies are looking for novel sites for clinical trials, Turkey, with her increasing number of medical schools and highly specialized trained clinicians and scientists, is becoming even more attractive as an investment and professional site for clinical trials.” Clinical Scientific Research Potentials in Turkey 2007