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Land of Opportunity

Lying between Europe and Asia, Turkey covers a large area and has a population of over 76 million. The capital is Ankara, and Istanbul is its largest city, holding more than 10 million people. Other major metropolitan areas – each with over one million residents – include Izmir, Bursa and Adana.

Healthcare services have emerged as one of the country’s most important business areas in the 21st century, due to the ageing population and worldwide changes in socioeconomic structures. Inevitably, the risk of chronic diseases increases with an extended average life expectancy. Thus, it is expected that innovative new medicines will gain greater importance over time, as they help prevent disease and reduce treatment costs (1).

Turkey is located at the centre of an emerging region, where the number of industry-sponsored clinical trials is steadily growing. Many multinational pharmaceutical companies, which do not yet have offices in the country, are looking for ways to conduct their research projects there. The systematic and organised work Turkey has been doing to enhance its healthcare sector is beginning to be recognised by industry players.

Incidence of Disease

Diseases of the circulatory system are responsible for nearly 40% of deaths in the country (2). Indeed, Turkish women have the highest mortality rate from coronary heart disease in Europe (3). IMS Health reports that: “Turkey’s health disease burden and health indicators vary significantly from major urban centers, where they are approaching European standards, to outlying rural areas, particularly in Eastern Turkey, where tuberculosis (TB) and similar infections still occur” (4). According to a report by the University College London (UCL) School of Pharmacy (3):
  • The disease profile in Turkey is shifting away from infectious towards non-communicable diseases, which account for 70% of all mortality in the country
  • The incidence of type 2 diabetes has doubled in a little more than a decade, above the rate of increase in the US
  • More of the population is becoming obese (particularly less advantaged women), and about one quarter of adults in the country have ‘clinically significant’ raised cholesterol levels
  • At least a third of the population have clinically significant hypertension, nearly half of whom are unaware of their condition
In addition, nearly 150,000 new cancer patients are diagnosed each year (with lung being the most frequent tumour type), as indicated by the WHO (5).

Healthcare in Turkey

Turkey’s Healthcare Transformation Programme, which was implemented in 2004, marked a major development in public access to services and treatments. Doctor consultations per capita increased five-fold from 1.7% in 1994, to 7.7% in 2011. Innovative treatments are now playing a significant role in raising life expectancy; based on a study conducted by Professor Lichtenberg of Columbia University and the US National Bureau of Economic Research, novel drugs accounted for 75% of the increase in life expectancy across the 30 countries surveyed, including Turkey (6).

Types of Facilities


The number of hospitals in the country has climbed steadily since 2002. As of 2010, there are now more than 1,400 across three basic types of facilities.

Together, these institutions have 2.5 beds per 1,000 of the population and maintain a total bed occupancy rate of around 64%. The majority of admissions are to hospitals affiliated with the Ministry of Health (MOH).

Distribution of Hospitals
The number of private hospitals is growing rapidly, and they hold vast potential as future trial sites. The distribution of these is heavily weighted towards three leading cities – Istanbul, Ankara and Izmir – which, together, hold 48% of private institutions and 56% of the total available beds.

Providing medical care to those in social security is becoming more costly each day, and these expenses are put on the patient, adding additional burden. Because of this, participation in clinical trials is becoming increasingly attractive to the Turkish population, as all study-related expenses can be reimbursed to the hospitals by sponsors, while full medical care is provided at no extra cost – meaning a mutual benefit for both the institution and patient. This way, sponsors also have the chance to obtain adequate data for their research.

This too has had a positive impact on triggering clinical trials in private settings. The legislation allowing research to be conducted in private hospitals is rather new – thus, few have conducted studies in these institutions to date, and most of those that have been carried out have been in university hospitals and those affiliated with the MOH (7).

Healthcare Professionals

Currently, there are a total of 130,000 doctors in Turkey (8). Of these, 75,000 are working within the MOH environment and, of those, 33,812 are specialists, 32,607 are general practitioners and 8,500 are assistants. Istanbul, Ankara and Izmir are the leading cities in terms of the number of doctors, with 30% of the country’s total found here.

Slightly less than two thirds (59%) of Turkish doctors work in MOH-affiliated state hospitals, while 20% work in private settings (9).

Clinical Trials

The first regulations for conducting trials in Turkey were introduced in 1993 and, over the past 20 years, the country has come a long way in supporting clinical research. Today, it is a serious candidate for becoming a clinical research hub in the Eastern Europe-Middle East-North Africa triangle.

Organisations such as the Association of Research-Based Pharmaceutical Companies (AiFD), the Foundation for Clinical Research, and the Foundation of Contract Research Organizations all work to enhance the study environment in Turkey. The AiFD’s vision is that the country will become an R&D and manufacturing centre on a global scale – a goal reflected in its motto: “2023 will come as the remedy” (6) (see Figure 4, page 61).

The Numbers

As of September 2014, approximately 1% (1,616) of the world’s 174,221 clinical research projects had been conducted in Turkey (10). According to the World Economic Forum’s Global Competition Index (2011-2012), while the Turkish pharma sector is ranked 16th in terms of market value, it is 36th when it comes to the clinical research conducted and the volume of pharmaceutical exports (11). However, the number of trials in Turkey has been climbing steadily for the past few years; between 2012 and 2013, the country’s total increased 12%. The majority of those carried out are Phase 3, although sponsors are implementing studies of all phases in the country.

Regulatory Process
Recent measures to improve the applicable regulations have strengthened interest in conducting clinical research in Turkey. The country has taken major steps towards harmonising its research legislation with that of the EU, and its regulations are now completely in line with European Commission Directives (EC 2001/20 and EC 2005/28). Trial legislation is reviewed periodically and amended as required, to comply with the most stringent international standards and ethical principles.

The MOH has created a clinical research unit which has the authority to assess and grant approvals for studies. Submissions must be made to both the MOH and a local ethics committee. Such committees have been established in all localities – with 99 being approved at the time of writing – and members are required to have had training in Good Clinical Practices (GCPs). Applications can be submitted to any approved ethics committee, and the decision of just one of these bodies is sufficient for a multicentre trial.

Importing intellectual property requires a pro forma invoice for the shipment, an import customs declaration and relevant international shipping documents. Under normal circumstances, approval is granted in around 15 days, and the entire process is expected to take between 45 and 60 days, as indicated in the regulation published by the MOH. However, from time to time, this period is likely to extend to around 90 days, depending on the workload of the ethics committee. Generally, the best case is to initiate a project within 75 days, including obtaining receipt of the import licence.

The current Turkish regulation on clinical research (originally published on 13 April 2013) was updated on 25 June 2014, making it even easier to start and conduct trials in the country, due to the following changes:
  • Both the MOH and ethics committee submissions can now be completed in parallel, saving considerable time for sponsors and CROs
  • Submissions to the MOH can be made electronically – another time-saver for sponsors
  • Applications can be sent to any ethics committee, whether or not it is involved in the particular research project
  • Clinical trials can be performed in private settings
  • Study documents must be archived for five years (instead of 14)
The update also mandates that all clinical trials must be published in a public internet database, managed by the MOH. However, the Clinical Research Association in Turkey has also created a similar site – clinicaltrials-tr.org – in cooperation with the clinicaltrials.gov database.

Why Turkey?


Turkey is one of the most convenient and productive countries in which to invest for clinical research, and is aiming to become one of the foremost countries in the Europe, Middle East and Africa region (12). The economy is one of the fastest growing in the world, and the volume of pharmaceuticals imported and exported has increased two-fold in the last five years.

The country represents a fertile market in the clinical research business, boasting:
  • A developing clinical research profile, supported by new regulations that are in accordance with international standards and European directives
  • A large and diverse patient population of almost 80 million, the majority of whom are treatmentnaïve. Consequently, Turkish people are highly motivated to participate in studies, and ready access to them makes for rapid enrolment
  • A high number of sites with the capacity to conduct clinical research: 62 university hospitals, 489 private hospitals and 843 government hospitals (13)
  • Highly motivated research teams trained in GCP, capable of producing high-quality, reliable data
  • Comparatively low costs, relative to EU countries and the US
Regional Challenges

Although most doctors in Turkey work in hospitals affiliated with the MOH, conducting clinical research in such settings requires approval from the Association of Public Hospitals. Because the Association is also involved in clinical trial agreements, this sometimes delays study start-up. Fortunately, the Turkish MOH is working to create common standards in such hospitals, where current fees for physical examinations, tests and procedures vary from one facility to another.

Other restrictions that may impede site and patient enrolment include:
  • No payments can be made to assistant personnel
  • No advertising can be done to recruit patients for clinical trials
  • No payments can be made to patients in return for their study participation
Another possible limiting factor is that investigators cannot be paid directly for their trial involvement; payments must be made to the circulating capital department of the relevant institutions. Ultimately, researchers only receive an average of 60% of the investigator fees that sponsors pay.

There are still a number of inexperienced ethics committees in Turkey, so sponsors must take care to select ones that are sufficiently prepared. This is easier now that applications can be sent to any ethics committee, rather than only those involved in a particular project.

Exploring Potential

When considering study locations, sponsors seek countries with a well-established structure, a solid understanding of – and adherence to – global clinical trial management practices, and a sufficient number of target patients. They also, of course, want to ensure that their research project delivers high-quality data in a timely manner.

Turkey meets all of these basic requirements, as well as offering an expedient regulatory process, competitive costs, and a government committed to advances in public health and economic progress. The challenges to operating trials in Turkey are minor when weighed against the advantages, and can easily be surmounted with the help of a partner that is familiar with the local practices and restrictions. Sponsor companies would do well to fully explore what Turkey has to offer their research programmes.

References


1. Visit: www.turkstat.gov.tr/start.do
2. Causes of death statistics, 2010, 2011 and 2012, Turkish Statistical Institute, No 15847, 16 April 2013
3. Transforming health in Turkey: 21st century opportunities, UCL School of Pharmacy, September 2012
4. IMS Health, Country report: Turkey, Pharmaceutical Market Europe, May 2011
5. World Health Organization International Agency for Research on Cancer, Globocan 2012: Estimated cancer incidence, mortality, and prevalence worldwide in 2012 6. Visit: www.aifd.org.tr/pdf/2023_rapor/2023_strat_en.pdf
7. Turkish Official Gazette, No 28617, 13 April 2013
8. Visit: www.sabah.com.tr/saglik/2014/03/13/turkiyede-bir-doktora-590-kisi-dusuyor
9. Annual Health Statistics, 2010
10. Visit: www.clinicaltrials.gov
11. Visit: www.aifd.org.tr/pdf/2023_rapor/2023_strat_en.pdf
12. Visit: http://www.klinikarastirmalar.org.tr/admin/spaw/uploads/files/Recent-Changes-in-Clinical-Trials-regulationsin-turkey-are-shortening-the-start-up-period-of-clinical-trials.pdf
13. TurkStat, Turkish agency of statistics – Hospital number report, June 2012



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Ömer Sadun Okyaltırık began his career in pharmaceuticals in 1994, with a focus on clinical research since 2001. Having started at Roche Turkey as a sales representative, he has held several positions – such as Product Manager, Clinical Research Associate (CRA) and Senior CRA – in companies including Pfizer, Aventis/Sanofi-Aventis and PPD. Currently, Ömer is Country Manager and Clinical Operations Manager for Pharm-Olam Turkey.

Dr Yamin ‘Mo’ Khan joined Pharm-Olam International in May 2000 and has worked across various departments, including clinical operations, business development, and project and executive management. His current role is Executive Vice President of Global Clinical Development and, prior to this, Mo held positions at Innovex and Quintiles in clinical and project management, as well as at The Liposome Company. He has both a BSc and PhD in Biochemistry, from the University of Liverpool and the University of Southampton, respectively.
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Ömer Sadun Okyaltırık
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Dr Yamin ‘Mo’ Khan
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