Türkiye – a Hidden Gem in Clinical Research
Firstly, it is official – Turkey is now Türkiye. This change took place past summer when the United Nations officially recognized the new name.
With a population of over 85 million, a well developed universal healthcare system, a relatively low per capita number of clinical trials, a large pool of treatment-naive patients, Türkiye is a hidden gem in clinical research. This is the reason why the number of biotech and pharma companies that are getting engaged in Türkiye has been on the rise and the volume of clinical trials has been doubling for the last 3 years.
Over the past couple of decades, the country has steadily worked its way to establish a strong reputation in the area of clinical trials. Today, the efforts have come to fruition, as seen by the rising number of stakeholders looking at Türkiye for their next trial.
This article gives a brief overview of the current state of clinical research in Türkiye.
Country Overview
Türkiye, officially known as the Republic of Türkiye, lies between two continents: Europe and Asia. It is situated at the crossroads of the Balkans, Caucasus, Middle East, and eastern Mediterranean. Its transcontinental location enables it to form strong economic and academic connections with the surrounding countries.
According to the most recent United Nations World Statistics Pocketbook, its land area covers more than 780 thousand square kilometers.
Demographics
The World Bank data from 2021 indicates that there are more than 85 million people residing in the country.
One of the indicators of Türkiye’s improving research culture is its Global Innovation Index, where it is ranked 4th in the region as of 2021. The GII measures the capability of countries to plan and execute innovative research, both medical and otherwise.
Socioeconomics
The national capital of Türkiye is Ankara, although the most populated city is Istanbul. A large number of potential clinical research participants are concentrated in these two cities.
The UN data shows that Türkiye’s major trade partners include Germany, the US, the UK, and China. Türkiye also participates in economic activities with EU countries through the EU-Türkiye Trade Union. Having diplomatic ties with neighboring countries helps secure resources that are essential to the clinical research sector.
At a Glance: Türkiye’s Health and Pharmaceutical Industry
- As of the year 2020, the life expectancy at birth is 78 years on average. The share of people older than 69 is 6.1%.
- Data from UNICEF (2020) indicate that the infant mortality rate is 9.5 deaths per 1000 live births.
- Anadolu Agency, a state-run news network in Türkiye, reported that the pharmaceutical market in the nation reached $6.7 billion in 2020. The country now has more than a 100 pharmaceutical plants, 33 R&D centers, and manufactures around 12,000 medical products.
Status of the Healthcare Sector in Türkiye
Based on Statista , a market and consumer data company, the healthcare expenditure of Türkiye as of 2020 was 5% of its GDP. While lower than other OECD-European countries, this percentage is expected to grow in parallel with the country’s pharmaceutical industry.
Türkiye’s government is implementing measures to accommodate the health-related needs of its residents by building its healthcare infrastructure. As of 2020, the country had 1538 hospitals, 143000 public hospital beds, and 172000 physicians.
Another fascinating facet of the nation’s healthcare system is its public health insurance. Statista reports that as of 2020, an astounding 98.5% of Türkiye’s population is covered by public health insurance. Included in healthcare policy are laboratory tests, drugs, medical devices, consulting with physicians, and many other benefits.
The country has developed the reputation for having an advanced medical system and high quality healthcare that is attested by it being one of the top 10 destinations for medical tourism.
Reasons to Conduct Clinical Trials in Türkiye
When it comes to the conduct of clinical trials, this nation can be considered one of the emerging players on the world stage. According to the 2020 report published by the European Federation of Pharmaceutical Industries and Associations (EFPIA), Türkiye ranks 26th globally in terms of the number of performed clinical trials .
This rather formidable ranking is a testament to Türkiye’s growing focus on clinical research. Here are some of the reasons why pharmaceutical and biotechnology companies are drawn to this country.
- High number of enthusiastic physicians and dedicated clinical research staff
- Higher percentage of treatment-naive patients interested in participating in clinical trials and easy access to them
- Well-reputed research sites with strong technological infrastructure capabilities, on par with international standards.
- Full compliance with GCP and quality standards
- Modest number of trials per patient
- Moderate clinical research costs and investigator fees
- GMP certificate is sufficient for regulatory submissions as the EU QP Statement is not required
Türkiye: Quick Facts
Regulatory approval process
CEC and RA (MoH) submissions can be performed in parallel. Original CEC approval must be submitted to RA, and IL submission can be performed when RA approval is obtained.
Agreements with sites and investigators
Usually, site agreements are tri-party (PI, Hospital, and Sponsor/CRO). Some of the sites may start reviewing/negotiation process prior to RA approval. Sites do not execute contracts without the RA approval.
EC review and approval
Local EC and RA (MoH) submission can take place in parallel. However, a study cannot be started without the RA approval.
Trial sites’ location
Main medical centers are located in major cities such as Istanbul, Ankara, and Izmir.
Legal entity
A local CRO or a CRO that has an affiliate in Türkiye can perform the submissions.
QP Declaration / GMP certificate
GMP Certificate is required for submission.
Documents requiring special attention
Insurance Agreement, ICF, Budget Form.
Official Language
Essential documentation should be submitted in English. Patient-related documents, Labels, Protocol synopsis must be translated into Turkish language.
Patient insurance
Both local and global insurances are accepted. For global insurance, the company must have an affiliate in Türkiye. Turkish certificate is to be wet ink signed and dated by the insurance company.
Useful tips
IMPD is not a mandatory document for submission. However, RA (MoH) may request it for Phase I-III studies.
Snapshot of Türkiye’s Clinical Trials
In total 903 clinical trials were initiated in Türkiye in the period from September 1, 2021 to September 1, 2022, according to data obtained from clinicaltrials.gov. The largest share is in the field of Neurology (105), followed by oncology (95) and orthopedics (71). Local Sponsors are responsible for 84% of the trials.
Regulatory Framework for Clinical Research in Türkiye
The main regulatory body involved in clinical trials is the Turkish Medicines and Medical Devices Agency or the TMMDA. The agency’s mission involves monitoring and evaluating the clinical trials of human medicines to ensure that they are safe and compliant with international standards and directives including EC 2001/20 and EC 2005/28.
The study also needs to receive an approval from the ethics committee. A single ethics committee of a participating site is sufficient for the approval of the entire trial. Such an ethics committee acts as a central ethics committee and grants approvals to study designs that observe good clinical practices and uphold appropriate ethical standards. Some of the guidelines that govern its work include:
- Good Clinical Practices and Good Manufacturing Practices Guidelines
- Guidelines for Ethical Approach to Clinical Research Conducted on Pediatric Populations
- Guidelines for Application to the MInistry of Clinical Research and Ethics Committees
Such guidelines are monitored thoroughly by TMMDA and other concerned regulatory bodies to ensure the safety of the volunteers. The strict adherence to international regulations for clinical trials is one of the key factors that attracts CROs and pharmaceutical companies to Türkiye.
Cromos Pharma – A Contract Research Organization with operations in Türkiye
Cromos Pharma has an experienced local team that effectively manages regulatory and contracting processes to ensure that studies can be initiated in the shortest period of time possible. We recruit highly educated and experienced staff that assures that each trial managed by our team in Türkiye produces exceptional data quality and reliable results.
Cromos Pharma combines global expertise with in-depth local experience and knowledge that translates into exceptional patient recruitment. Our team has met or reduced enrollment timelines in 95% of the conducted trials.
In case you are considering conducting clinical trials in Türkiye, the Cromos Pharma team would be happy to answer any of your questions.
