Review

Opinions about the future of Clinical Trial in Turkey

Volume: 7 Number: 3 September 2, 2016
EN

Opinions about the future of Clinical Trial in Turkey

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. 

Keywords

References

  1. 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. 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. 3. SB Tıbbi Cihaz Klinik Araştırmaları Yönetmeliği.2015
  4. 4. <>, erişim tarihi:10.02.2016.
  5. 5. 2001/20/EC Direktifi.
  6. 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. 7. 2014/536/EC Direktifi
  8. 8. http://ec.europa.eu/health/files/eudralex/vol1/reg_2014_536/reg_2014_536_en.pdf, erişim tarihi:10.02.2016.

Details

Primary Language

Turkish

Subjects

Health Care Administration

Journal Section

Review

Publication Date

September 2, 2016

Submission Date

May 1, 2016

Acceptance Date

June 20, 2016

Published in Issue

Year 2016 Volume: 7 Number: 3

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