Cr In Turkey


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Cr In Turkey

  1. 1. Clinical Research in Turkey prepared by Miacheal Morgan Kuantum 2008
  2. 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. 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. 4. Clinical Trials 1997-2006 400 300 200 100 0 1997 1999 2001 2003 2005 clinical trials other trials total number of trials
  5. 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. 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. 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. 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. 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. 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