Opinions about the future of Clinical Trial in Turkey

Year 2016, , 258 - 264, 02.09.2016

Nüket Büken

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. 

Keywords

Clinical research, non-interventional clinical research, regulation

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.