Expert Interviews
Charting New Paths: Turkey's Journey in Clinical Trials Discovery
Welcome to an engaging interview about clinical research in Turkey! In this conversation, we’ll explore the advantages, challenges, and emerging trends in conducting clinical trials in this dynamic country. Discover how Turkey has become a prominent destination for medical research and how it’s contributing to global innovation.
Joining us today is Merter Ortac, a seasoned expert in Medical Devices, Oncology, Hematology, Clinical Monitoring, and Good Clinical Practice (GCP). With a robust background in business development and a Master’s degree in Japanese Language and Literature from Ankara Üniversitesi, Merter brings a unique and insightful perspective to the discussion on clinical research in Turkey.
ABRS: What unique challenges does clinical research in Turkey face compared to other regions of the world?
Merter: There are no significant difficulties in conducting clinical studies in Turkey, which has European Union (EU) compatible legislation, compared to other parts of the world. However, the approval processes of the ethics committee and the Ministry of Health in Turkey can be challenging. Particularly in medical device studies, parallel applications cannot be made. The lack of standardization in the functioning of clinical research ethics committees is being addressed with the restructuring of ethics committees by the Ministry of Health in 2024, and improvements in timelines are planned.
ABRS: What specific advantages does Turkey offer as a destination for conducting clinical trials?
Merter: Turkey offers several advantages, including a high population, high patient diversity, and a high incidence and diversity of rare diseases. The country also has a developed health system, availability of qualified physicians and investigators, compatibility with European Union (EU) legislation, and an advantageous geographic location.
ABRS: What are the most critical aspects to consider when designing and executing a clinical trial in Turkey, both from a regulatory and operational perspective?
Merter: Clinical trials must be designed, conducted, recorded, and reported in accordance with ethical and scientific quality standards guided by ICH-GCP. This ensures the protection of trial participants’ rights, health, and privacy, as well as the reliability of the data obtained from the trial.
ABRS: What role do CROs play in the successful development and execution of clinical trials in Turkey, and what are the benefits of working with them?
Merter: One of the most important advantages of working with a CRO in Turkey is cost savings. Clinical studies can be prohibitively expensive and require specialized personnel, equipment, and facilities. With their expertise and resources, CROs can often perform the same tasks at a fraction of the cost.
Globally, clinical trials often span multiple countries. CROs have the global reach and local knowledge to manage such complex multi-site studies, ensuring they meet the regulatory requirements.
Another reason why CROs are important is their expertise. Pharmaceutical companies often have a broad focus from R&D to marketing. On the other hand, CROs specialize in specific aspects of drug development, providing a level of expertise that is difficult to achieve.
Drug development is fraught with both financial and clinical risks. CROs help reduce these risks by ensuring studies are conducted ethically and scientifically and adhering to all regulatory rules. This not only protects subjects but also protects pharmaceutical companies from potential legal problems.
ABRS: What are the emerging trends or areas of growth in clinical research in Turkey, and how are they contributing to innovation in the industry on a global scale?
Merter: Turkey has adapted relatively quickly to the transition to new drug types and complex treatments among global clinical research trends. Especially in recent years, the main factors for the growth of clinical trials in Turkey include Phase III studies in the field of oncology and immunotherapy, which are conducted jointly in more than one country. Additionally, Turkey has become successful in recruiting patients for biosimilar drug studies. From this perspective, Turkey has begun to build its basic clinical research experience to support its goal of implementing projects for the development of value-added precision and translational medicines targeting cancer, chronic diseases, and rare diseases.
On the other hand, there are still many opportunities to increase the effectiveness and efficiency of clinical research processes in Turkey to gain a global competitive advantage. This can be achieved partly through Turkey’s digital transformation (an important tool in the 11th Development Plan) and partly through adequate incentives to support R&D.
Although some trends, such as the use of digital health technologies, mobile technologies, patient-reported outcomes, and changes in medication types, have begun to be implemented in Turkey, all of these trends are open to development and growth.
We want to express our sincere gratitude to Merter for sharing his valuable insights and perspectives on clinical research in Turkey. His comments have shed light on this country’s uniqueness and potential in clinical trials. We hope this interview inspires our readers and fosters a deeper understanding of Turkey’s crucial role in advancing medicine globally. Thank you, Merter, for your time and dedication!