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Opinions about the future of Clinical Trial in Turkey

Year 2016, , 258 - 264, 02.09.2016
https://doi.org/10.5799/jcei.328618

Abstract

Even though all the rights and obligations of all parties of clinical trial – the researching physician, the volunteering
patient, the industry, research institutions- have been assured with ethico-legal regulations, there still exist many
problems in the world of clinical research, and suggestions of solutions to the said problems.
As a medical ethicist who has been a permanent member of the Hacettepe University Ethical Committee since 2000, I
have decided to write a short report that is a general look at the world of clinical research in Turkey. I wanted this report
to be one that talks about some of the issues I believe are important about this subject, which include expectations and
predictions on it.
All of the headlines in this report are without doubt, issues that can be researched and written about widely and with
much more details. Especially the process of adjustment to the new regulation of the EU (No 536/2014 of The European
Parliament), the condition of non-medicational/non interventional clinical research, transparency in clinical research
and budget issues are to me controversial subjects that should be especially and primarily discussed. 

References

  • 1. The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No 164) was opened for signature on 4 April 1997 in Oviedo (Spain).
  • 2. SB İlaç ve Biyolojik Ürünlerin Klinik Araştırmaları Hakkında Yönetmelik http://www.saglik.gov.tr/GETAT/belge/1-38934/ilac-ve-biyolojik-urunlerin-klinikarastirmalari-hakkin-.html , erişim tarihi:10.02.2016.
  • 3. SB Tıbbi Cihaz Klinik Araştırmaları Yönetmeliği.2015
  • 4. <<http://www.ttb.org.tr/mevzuat/index.php?option=com_content&view=article&id=1009:2014-09-08-06-30-04&Itemid=33 >>, erişim tarihi:10.02.2016.
  • 5. 2001/20/EC Direktifi.
  • 6. http://ec.europa.eu/health/human-use/clinicaltrials/directive/index_en.htm, http://ec.europa.eu/health/files/eudralex/vol1/dir_2001_20/dir_2001_20_en.pdf, erişim tarihi:10.02.2016.
  • 7. 2014/536/EC Direktifi
  • 8. http://ec.europa.eu/health/files/eudralex/vol1/reg_2014_536/reg_2014_536_en.pdf, erişim tarihi:10.02.2016.
  • 9. https://www.era-learn.eu/networkinformation/networks/e-rare-3/e-rare-3-jtc-2015, erişim tarihi:10.02.2016.
  • 10. https://clinicaltrials.gov/, erişim tarihi:10.02.2016.
  • 11. Klinik Araştırmalar Portalı, http://kap.titck.gov.tr/, erişim tarihi:10.02.2016.
  • 12. Büken NÖ “Türkiye’de Klinik Araştırmalar Açısından 2015 yılında Etik / Sağlık Politikaları Bağlamında Neler Yaşandı? Öngörüler Nelerdir?”, TBD e.bülten, 2015;23. http://www.biyoetik.org.tr/wpcontent/uploads/2015/08/bulten23.pdf.
  • 13. HÜ Biyoetik Merkezi, Araştırma Biyobankacılığı Rehberi, http://www.hubam.hacettepe.edu.tr/arsiv/arastir ma_bankaciligi.php , erişim tarihi:10.02.2016.
Year 2016, , 258 - 264, 02.09.2016
https://doi.org/10.5799/jcei.328618

Abstract

References

  • 1. The Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (ETS No 164) was opened for signature on 4 April 1997 in Oviedo (Spain).
  • 2. SB İlaç ve Biyolojik Ürünlerin Klinik Araştırmaları Hakkında Yönetmelik http://www.saglik.gov.tr/GETAT/belge/1-38934/ilac-ve-biyolojik-urunlerin-klinikarastirmalari-hakkin-.html , erişim tarihi:10.02.2016.
  • 3. SB Tıbbi Cihaz Klinik Araştırmaları Yönetmeliği.2015
  • 4. <<http://www.ttb.org.tr/mevzuat/index.php?option=com_content&view=article&id=1009:2014-09-08-06-30-04&Itemid=33 >>, erişim tarihi:10.02.2016.
  • 5. 2001/20/EC Direktifi.
  • 6. http://ec.europa.eu/health/human-use/clinicaltrials/directive/index_en.htm, http://ec.europa.eu/health/files/eudralex/vol1/dir_2001_20/dir_2001_20_en.pdf, erişim tarihi:10.02.2016.
  • 7. 2014/536/EC Direktifi
  • 8. http://ec.europa.eu/health/files/eudralex/vol1/reg_2014_536/reg_2014_536_en.pdf, erişim tarihi:10.02.2016.
  • 9. https://www.era-learn.eu/networkinformation/networks/e-rare-3/e-rare-3-jtc-2015, erişim tarihi:10.02.2016.
  • 10. https://clinicaltrials.gov/, erişim tarihi:10.02.2016.
  • 11. Klinik Araştırmalar Portalı, http://kap.titck.gov.tr/, erişim tarihi:10.02.2016.
  • 12. Büken NÖ “Türkiye’de Klinik Araştırmalar Açısından 2015 yılında Etik / Sağlık Politikaları Bağlamında Neler Yaşandı? Öngörüler Nelerdir?”, TBD e.bülten, 2015;23. http://www.biyoetik.org.tr/wpcontent/uploads/2015/08/bulten23.pdf.
  • 13. HÜ Biyoetik Merkezi, Araştırma Biyobankacılığı Rehberi, http://www.hubam.hacettepe.edu.tr/arsiv/arastir ma_bankaciligi.php , erişim tarihi:10.02.2016.
There are 13 citations in total.

Details

Subjects Health Care Administration
Journal Section Collection
Authors

Nüket Büken

Publication Date September 2, 2016
Published in Issue Year 2016

Cite

APA Büken, N. (2016). Opinions about the future of Clinical Trial in Turkey. Journal of Clinical and Experimental Investigations, 7(3), 258-264. https://doi.org/10.5799/jcei.328618
AMA Büken N. Opinions about the future of Clinical Trial in Turkey. J Clin Exp Invest. September 2016;7(3):258-264. doi:10.5799/jcei.328618
Chicago Büken, Nüket. “Opinions about the Future of Clinical Trial in Turkey”. Journal of Clinical and Experimental Investigations 7, no. 3 (September 2016): 258-64. https://doi.org/10.5799/jcei.328618.
EndNote Büken N (September 1, 2016) Opinions about the future of Clinical Trial in Turkey. Journal of Clinical and Experimental Investigations 7 3 258–264.
IEEE N. Büken, “Opinions about the future of Clinical Trial in Turkey”, J Clin Exp Invest, vol. 7, no. 3, pp. 258–264, 2016, doi: 10.5799/jcei.328618.
ISNAD Büken, Nüket. “Opinions about the Future of Clinical Trial in Turkey”. Journal of Clinical and Experimental Investigations 7/3 (September 2016), 258-264. https://doi.org/10.5799/jcei.328618.
JAMA Büken N. Opinions about the future of Clinical Trial in Turkey. J Clin Exp Invest. 2016;7:258–264.
MLA Büken, Nüket. “Opinions about the Future of Clinical Trial in Turkey”. Journal of Clinical and Experimental Investigations, vol. 7, no. 3, 2016, pp. 258-64, doi:10.5799/jcei.328618.
Vancouver Büken N. Opinions about the future of Clinical Trial in Turkey. J Clin Exp Invest. 2016;7(3):258-64.