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

Abstract

INTRODUCTION[|]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 course of the 24 years. [¤]METHODS[|]The ClinicalTrials.gov website and its advanced filtering were used to identify registered CTs performed in Turkey during four six-year intervals. Various characteristics of the CTs, such as design, phase distribution, participant age, and type of funding, and the percentage 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 studies between 01/01/2012 and 01/01/2018. Phase distribution analysis showed that there were more late-phase CTs than early-phase CTs in Turkey during the study period.[¤]DISCUSSION AND CONCLUSION[|]Modernization of Turkey's regulations for CTs facilitated the relevant growth of CTs in Turkey. Considering Turkey's unique geographic location, technological advancements, and ease of patient recruitment, the observed exponential increase in the number of CTs performed is not surprising. The higher number of late-phase CTs, as compared to early-phase CTs in Turkey, indicates that late-phase CTs may be more common in developing countries because they are less expensive to conduct that early-phase CTs and the pool of potential participants are naive.[¤]

Keywords

• clinical trial phase distribution
• clinical trials; turkey.