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Journals / Southern Clinics of Istanbul Eurasia / 2020 / Cilt: 31 - Sayı: 2

Development of Clinical Trials in Turkey After the Adoption of Clinical Drug Research Regulation

Klinik İlaç Araştırma Yönetmeliğinin Kabulu Sonrası Türkiye’de Yapılan Klinik Çalışmaların Gelişmesi

Alihan SÜRSAL
Fehmi NARTER
Fatih ÖZDENER
Pages
171–176
Publication Date
2022-10-19
DOI
—
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AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

The higher number of late-phase CTs, as compared toearly-phase CTs in Turkey, indicates that late-phase CTs may be more common in developingcountries because they are less expensive to conduct that early-phase CTs and the pool ofpotential participants are naive.

📌 3 Key Takeaways

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Objective & Hypothesis:Objective: This study aims to investigate the effects of Turkey’s adoption of clinical trial(CT) regulations and international guidelines on CTs conducted in Turkey over the courseof the 24 years.Methods: The ClinicalTrials.gov website and its advanced filtering were used to identifyregistered CTs performed in Turkey during four six-year intervals.
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Key Findings & Data:Various characteristicsof the CTs, such as design, phase distribution, participant age, and type of funding, and thepercentage of surgery-related CTs, were analyzed.Results: The number of CTs conducted in Turkey increased exponentially during the 24-year study period, from 23 studies between 01/01/1994 and 01/01/2000 to 1930 studiesbetween 01/01/2012 and 01/01/2018.
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Conclusion & Impact:The higher number of late-phase CTs, as compared toearly-phase CTs in Turkey, indicates that late-phase CTs may be more common in developingcountries because they are less expensive to conduct that early-phase CTs and the pool ofpotential participants are naive.
🔬Design:Lab & Field Experiment
📍Scope:2000 Verileri
⚙️Variables:Domain Parameters

Abstract

Objective: This study aims to investigate the effects of Turkey’s adoption of clinical trial(CT) regulations and international guidelines on CTs conducted in Turkey over the courseof the 24 years.Methods: The ClinicalTrials.gov website and its advanced filtering were used to identifyregistered CTs performed in Turkey during four six-year intervals. Various characteristicsof the CTs, such as design, phase distribution, participant age, and type of funding, and thepercentage of surgery-related CTs, were analyzed.Results: The number of CTs conducted in Turkey increased exponentially during the 24-year study period, from 23 studies between 01/01/1994 and 01/01/2000 to 1930 studiesbetween 01/01/2012 and 01/01/2018. Phase distribution analysis showed that there weremore late-phase CTs than early-phase CTs in Turkey during the study period.Conclusion: Modernization of Turkey’s regulations for CTs facilitated the relevant growthof CTs in Turkey. Considering Turkey’s unique geographic location, technological advancements, and ease of patient recruitment, the observed exponential increase in the numberof CTs performed is not surprising. The higher number of late-phase CTs, as compared toearly-phase CTs in Turkey, indicates that late-phase CTs may be more common in developingcountries because they are less expensive to conduct that early-phase CTs and the pool ofpotential participants are naive.

Özet

Amaç: Bu çalışma, Türkiye’nin klinik çalışmaların yürütülmesi konusunda uyguladığı uluslararası yönetmeliğin etkilerini 24 yıllık bir dönem içinde göstermektedir. Gereç ve Yöntem: ClinicalTrial.gov sitesi ve içerisinde sunulan filtreler kullanılarak klinik çalışma sayıları kategorize edilmiştir. Bu araştırmalar altı yıllık dört farklı zaman aralığı kullanılarak yapıldı. Çalışmaların çeşitleri, faz dağılımları, yaş aralıkları, sponsor çeşitleri ve cerrahi klinik çalışmaların tüm çalışmalara oranı incelendi. Bulgular: Türkiye’nin konusu geçen 24 yıllık dönemine bakıldığında yürütülen klinik çalışmaların sayısının katlanarak arttığı gözlemlendi. 01.01.1994 ile 01.01.2000 tarihleri arasında kayıtlı 23 klinik çalışma, 01.01.2012 ile 01.01.2018 tarihleri arasında 1930’a yükselmiştir. Buna ek olarak, Türkiye’de geç fazlı çalışmalara, erken fazlı çalışmalara kıyasla daha büyük bir eğilim olduğu görüldü. Sonuç: Türkiye’nin klinik ilaç araştırma yönetmeliğindeki reformu, inovatif tıp için uyumlu bir alan yaratmıştır. Türkiye’nin benzersiz coğrafi konumu, teknolojik gelişmeleri ve hedef hasta kitlesinin uygunluğu göz önünde bulundurulduğunda bu ivmeli artış beklenmedik değildir. Türkiye’deki geç fazlı çalışmaların sayısının erken fazlı çalışmalara kıyasla az oluşu, gelişmekte olan ülkelerde olası düşük maliyet ve tedavi edilmemiş hasta grubunun varlığı nedeniyle oluşan çekiciliği yansıtmaktadır.

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Cite This Article

SÜRSAL, A., NARTER, F., ÖZDENER, F. (2022). Development of Clinical Trials in Turkey After the Adoption of Clinical Drug Research Regulation. Southern Clinics of Istanbul Eurasia, Cilt: 31 - Sayı: 2, 171–176. https://ajindex.com/articles/592806

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