Buket ERBAYRAKTAR, Burç AYDIN, Mustafa Cenk ECEVİT, Yeşim TUNÇOK

Clinical Research Infrastructure in Turkey: a Pilot Strengths, Weaknesses, Opportunities, Threats Analysis

Objective: The purpose of the study was to evaluate the infrastructure facilities of clinical trial units in Turkey to create descriptive information and perform a pilot strengths, weaknesses, opportunities, and threats SWOT analysis that describes the strengths to match them with the opportunities and aims to reduce weaknesses and threats. Methods: This study was conducted using the data provided by nine clinical trial units within the scope of a collaboration agreement signed with Turkish Clinical Research Infrastructure Network between April 2013 and December 2016, using a survey created and applied with Google Forms application. Descriptive statistics was used to summarize infrastructure and capacity questions. Mean and median were calculated to interpret the current data. A pilot SWOT analysis was performed to evaluate the clinical research environment in Turkey.Results: The number of clinical trials conducted varied over a wide range among the units. Most trials were conducted in the area of pediatrics, with the least number of trials being conducted in the area of endocrinology. Most units conducted national singlecenter trials with public funds. Physicians were mostly involved in clinical trials, and the number of nonprofessional healthcare personnel was limited. Application to the Ethics Committees and MoH was the most provided service among clinical trials units, where monitoring was the least provided service. None of the units had quality certification. A wide range of evaluations and suggestions concerning the clinical trial environment in Turkey was provided in this pilot SWOT analysis.Conclusion: As these weaknesses and threats with the data, provided by the units, are consistent with the concerns expressed by the national policy makers, suggestions expressed in the survey to improve the clinical research capacity and environment in Turkey should be considered for future actions

Keywords:

Clinical trial unit, clinical research infrastructure, SWOT analysis,

PDF

___

Search Results for Turkey. Available at: https://clinicaltrials. gov/ (Access date: 24.08.2016).
Ilbars H, Ozkan G. Ministry of Health, Turkish Medicines and Medical Device Agency Clinical Trials Workshop Report. An- kara. February 2015.
Ministry of Science, Industry and Technology. Turkey’s Pharmaceutical Industry Strategy Document and Annual Report (2015-2018). Available at: http://www.resmigazete. gov.tr/eskiler/2015/08/20150809-16-1.pdf (Access date: 11.08.2015).
Turkish Ministry of Development. The Tenth Development Plan (2014-2018) The Drugs Working Group’s Report. 2014. Available at: http://www.kalkinma.gov.tr/Lists/zel%20htisas%20Komisyonu %20Raporlar/Attachments/238/%C4%B0la%C3%A7%20 %C3%87al%C4%B1%C5%9Fma%20Grubu%20Raporu.pdf (Ac- cess date: 28.05.2015).
Ministry of Science, Industry and Technology. Turkey’s Biotech- nology Strategy Document (2015-2018). Available at: http://www. resmigazete.gov.tr/main.aspx?home=http://www.resmigazete. gov.tr/eskiler/2015/06/20150629.htm&main=http://www.re- smigazete.gov.tr/eskiler/2015/06/20150629.htm (Access date: 11.08.2015).
Economic Policy Research Foundation of Turkey. Pharma- ceutical R&D Ecosystem Report. April 2015. Available at: 7. Technology Development Foundation of Turkey. Medical Device Sector in World and Turkey and a Strategic Plan. August 2013. Available at: http://www.seis.org.tr/wp-con- tent/uploads/2016/01/2013-dunyada-ve-turkiye-de-tib- bi-cihaz-sektoru-ve-strateji-onerisi.pdf (Access date: 11.08.2015).
Forward Look - Investigator-driven Clinical Trials. European Science Foundation. Available at: www.esf.org/publications/ forward-looks.html (Access date: 16.08.2016). 9. The National Institute of Allergy and Infectious Diseases. Glossary of DAIDS Terms. Available at: http://www.niaid. nih.gov/labsandresources/resources/daidsclinrsrch/pages/ glossary.aspx
Regulation of Dokuz Eylül University Turkish Clinical Re- search Infrastructures Network Application and Research Center, Turkish Official Journal, 28425 (28 September 2012).
Orphan Drugs: R&D Challenges with Updates from Turkey and Middle East Countries.
Adams-Huet B, Ahn C. Bridging Clinical Investigators and Statisticians: Writing the Statistical Methodology for a Re- search Proposal. J Investig Med 2009; 57:818-824. [CrossRef]
Kleppinger CF, Ball LK. Building Quality in Clinical Trials with Use of a Quality Systems Approach. Clin Infect Dis 2010; 51:111-116. [CrossRef]
Tari JJ, Azorin JF, Heras I. Benefits of the ISO 9001 and ISO 14001 standards: A literature review. JIEM 2012; 5:297-322.[CrossRef]

Journal of Basic and Clinical Health Sciences-Cover

Yayın Aralığı: Yılda 3 Sayı
Başlangıç: 2016
Yayıncı: DOKUZ EYLÜL ÜNİVERSİTESİ

Arşiv