Turkey: Clinical Trial Fundamentals

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Becoming the clinical trials country leader in the region has been set as a primary goal for Turkey’s pharma industry to achieve global competitiveness. The government’s strategy is to increase its share of global clinical studies both in numbers and investment. Today, the country occupies the 26th position with 529 clinical trials in 2020.

 

On principle, that strategic decision makes sense since R&D is considered one of the most valuable investments pharmaceutical companies can provide as it relates to exposure to innovation for healthcare practitioners, researchers and patients. Within that paradigm, clinical trials are a natural proposition since over 60 percent of total pharmaceutical R&D investment is spent on them (phases I-IV).

The discrepancy between Turkey’s 26th global position in clinical trials and the size of the market, 18th globally, is something the industry is aiming to address. “At AIFD, we believe that the country can increase the clinical trials volume by three times to enter the global top 10,” says Janssen’s Demet Russ, who is also a board member of AIFD, the association representing multinational innovators.

As of June 2019, the total economic annual value of clinical research in Turkey is estimated at USD 327.7 million, according to IQVIA.

Government authorities, for their part, are embracing that proposition. According to the president of TITCK, Turkey’s regulatory body overseeing clinical research, the country has implemented initiatives in recent years to improve the clinical trials ecosystem, including a “solid legislative infrastructure” that follows European Union and ICH standards.

“[Turkey] has become a strong candidate for multinational clinical trials… Consistency and functionality of legal regulations and international standards create an environment of trust,” contends Dr. Tolga Karakan.

 

Not so fast…

“Changing regulations or laws in Turkey is difficult and takes time,” argues Dr. Hamdi Akan, president of Turkey’s Clinical Research Association, explaining that regulations are not “flexible” enough for adaptive clinical trials, for example, which are designs used increasingly for hematology, oncology or vaccines.

The vast majority of clinical trials conducted in Turkey are phase II and III studies, accounting for 93 percent of the total industry-sponsored trials, with Phase I being only 1 out 100. The reason, Dr. Akan says, is that accreditation of the centers from TITCK is not required for phase II-IV as they are with phase I trials.

He does, however, applaud Turkey’s adherence to the International Conference on Harmonization (ICH), saying that the ecosystem learned “a lot” through the process of harmonizing laws and clinical trials guidelines with EU regulations.

Dr. Akan believes that while medical infrastructure in Turkey is already globally competitive, the system needs more dedicated places to conduct clinical trials, an institutional centralized site coordinator, training programs, as well as transparent disclosure of clinical trials in a database, something that TITCK successfully developed but could be further improved.

 

The real prize?

While USD 327 million in R&D per year is quite an investment, a few stakeholders argue that more should be asked from multinational pharma companies than clinical trials. Of the 34 R&D centers in Turkey owned by private companies, less than 3 are owned by multinationals, Sanofi and Amgen amongst them.

“R&D centres are the real prize, where talent is developed, innovation created, and know-how distributed. People that leave those centres can later go to Turkish companies to advance their careers or become entrepreneurs, sharing the knowledge with the local ecosystem,” says Dogan Taskent, R&D head of Atabay.

Sceptical of Big Pharma’s proposition, Taskent argues that multinationals in Turkey promote their contribution in clinical trials, but “fail to mention that [they must conduct them] in order to sell the products in Turkey… Yes, clinical trials bring money to the country, but they are also a double-edged sword because they experiment with human beings that may or may not benefit.”

Nevertheless, he admits that clinical trials “are a necessary step to ensure that patients receive safe and effective drugs, but ethical grey areas exist,” and encourages multinationals to conduct more comprehensive R&D projects to leverage the low budget required for them in Turkey while maintaining the same quality.

Making a counterargument, industry executives suggest that convincing headquarters to open their wallets is a tough sell in a country where pricing pressure is constraining their growth.

Avinash Potnis from Novartis indicates that the pricing challenge could discourage companies from launching new therapies, thus affecting clinical trial investment “because it would not be ethical for companies to bring innovative treatments only to have those patients not be able to continue the treatment post-closure of trials.”

 

Tangible results

“Turkey is an important clinical studies hub for the organization due to the great capabilities of the centers and efficacy results,” says Güldem Berkman from Amgen, which owns Gensenta and its R&D center, and is investing in phase I and II trials.

Takeda is running 15 clinical trials in oncology, hematology, genetic diseases, and immunology; Bayer is doing 55 in 267 investigator sites; Novo Nordisk has 250 active researchers running 12 studies; and MSD is conducting 93 studies.

Janssen has invested USD 50 million in the last decade and has 47 ongoing trials, a number that has grown 50 percent in the last three years.


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