Clinical trials in Republic of Kazakhstan

Kazakhstan. Country Overview

Although the density of clinical trials in Kazakhstan is comparatively low, it could be a good place for clinical trials.

Kazakhstan offers access to a large and diverse population, which is very important for clinical trials. According to the World Bank, the estimated population of Kazakhstan in 2021 was approximately 19.1 million people. Kazakhstan is the ninth largest country in the world by territory.

The country has a diverse population with over 100 ethnic groups, the largest of which are Kazakhs and Russians. Other significant ethnic groups include Uzbeks, Ukrainians, Tatars, and Germans.

It is very convenient to conduct clinical trials in Kazakhstan because patients are concentrated in large cities. Kazakhstan has experienced significant urbanization in recent decades, with most of the population living in urban areas. According to the World Bank, approximately 67% of Kazakhstan's population lived in urban areas by 2021. This urbanization trend has been driven by a number of factors, including economic opportunities, access to education and healthcare, and improvements in infrastructure.

The country's largest city and commercial center is Almaty, with a population of over 2 million citizens. Other major cities in Kazakhstan include Nur-Sultan (the capital), Shymkent, Karaganda, and Aktobe.

Kazakhstan has a health care system that is largely publicly funded and administered by the government.

Kazakhstan has implemented universal health coverage, which aims to ensure that all citizens have access to basic health services. Although access to healthcare is universal, Kazakhstan stands out as a country that spends a relatively low percentage of its GDP on healthcare, which means that patients have access to cost-effective treatment options only.

Kazakhstan's healthcare system was developed on the Soviet model, which focused on early transition to specialized care and paid less attention to preventive services and the primary care sector, so Kazakhstan could be considered as a potential location for the study of treatment-naïve patients and patients with advanced stages of disease, as the prevalence of such patients is higher compared to European countries and western countries. However, it is worth mentioning that the government is making great efforts to improve the healthcare system.

In addition, out-of-pocket payments accounted for 42% of total healthcare spending in Kazakhstan in 2018. This means that patients in Kazakhstan still have to pay a significant portion of their healthcare costs out of pocket, despite the government's efforts to improve access to health insurance and reduce financial barriers to care. As a result, patients are highly motivated to participate in clinical trials in order to reduce the cost of medications and gain access to modern treatments provided by pharmaceutical companies.

According to the World Health Organization (WHO), there were approximately 56, 700 physicians in Kazakhstan in 2020. This corresponds to a physician density of about 3.0 physicians per 1, 000 inhabitants.

According to the World Health Organization (WHO), there was approximately 1, 800 hospitals in Kazakhstan in 2021. These hospitals are a mix of public and private facilities and are spread across the country's regions and cities.

According to the World Health Organization (WHO), there were approximately 105, 000 hospital beds in Kazakhstan in 2020. This represents a hospital bed density of approximately 5.5 beds per 1, 000 inhabitants, which is slightly higher than the global average of 3.4 beds per 1, 000 inhabitants.

Kazakhstan has a developed medical community and infrastructure. There are a number of individual researchers and institutions in Kazakhstan that have made significant contributions to scientific research. Most pharma companies are present on the market of Kazakhstan or EAEU. Some of the leading CROs have offices in Kazakhstan.

The leading causes of death in Kazakhstan are non-communicable diseases such as cardiovascular diseases, cancer, and respiratory diseases. Other major causes of death include external factors such as accidents, injuries, and homicides. Sponsors conducting clinical trials in the above indications may consider Kazakhstan for their clinical trials due to the access to a large number of patients and drug-naive patients.

According to the United Nations Educational, Scientific and Cultural Organization (UNESCO), the literacy rate in Kazakhstan was estimated to be around 99.8% for both males and females in 2021. High literacy results in transparent ICF process for patients.

The official language of Kazakhstan is Kazakh, but Russian is widely spoken and used in business and government. The Russian language may be an advantage for sponsors based in Russia and for sponsors who have already initiated a trial in Russia, as no additional investment in translation is required (except patients documents).

Kazakhstan has made significant progress in digitizing its healthcare system in recent years. Recognizing the potential of digital technologies to improve the accessibility, quality, and efficiency of healthcare services, the government has implemented a number of initiatives to promote the adoption of digital solutions in the sector.

One of the key initiatives in this area is the Digital Health program, which was launched in 2018. The program aims to modernize the country's healthcare system by introducing a range of digital technologies, including electronic health records, telemedicine, and mobile health solutions. The program also includes measures to improve cybersecurity in the healthcare sector and ensure the protection of patient data. Digitization could be a very useful tool in clinical trials for prescreening and identifying eligible patients for clinical trials.

The size of the pharmaceutical market in Kazakhstan is estimated to be around USD 1.6 billion in 2021. The market has been growing steadily in recent years, resulting in the growth of the clinical trials market and its infrastructure development.

Overall, the cost of living in Kazakhstan is relatively affordable compared to many other countries. According to the National Statistics Agency of the Republic of Kazakhstan, the average nominal monthly wage in Kazakhstan in 2021 was approximately 221, 500 tenge (approximately $520). It is worth noting that while the average salary in Kazakhstan may seem low compared to some developed countries, the cost of living in the country is also generally lower. This may be an attractive factor for companies with limited resources to conduct clinical trials or for small biotech companies.

Clinical Trials Landscape

The MOH of Kazakhstan has identified the clinical trials sector as a key strategic priority and has made significant efforts to develop it.

The Government of Kazakhstan has implemented measures to support the growth of the clinical trials sector, including the simplification of regulatory procedures and the establishment of a national clinical trials database. These efforts have helped to increase Kazakhstan's attractiveness as a destination for clinical research, and the country is expected to continue to grow in this area in the coming years.

The first international clinical trial was initiated in Kazakhstan in 2009. However, in recent years, interest in Kazakhstan and the number of completed and ongoing clinical trials has grown a lot.

There are 172 clinical trials registered on clinicaltrials.gov. The number of ongoing trials is 38. There is also a national clinical trials registry in Kazakhstan.

Regulatory Environment in Kazakhstan

Kazakhstan has a transparent regulatory environment. Approval of clinical trials is carried at several steps.

Initiation of clinical trials in Kazakhstan requires submission of trial-related documents to the National Center for Expertise of Medicines, Medical Devices and Medical Equipment.

The application is also reviewed by the Central Ethics Committee. The CEC review ensures that the medical research to be conducted meets and observes the highest standards of health care ethics.

The final decision to approve the clinical trial application is made by the Ministry of Health of Kazakhstan. On average, the entire process from submission of documents to final approval takes about 3 months.

Documents can be submitted in Russian. Patient-related documents must be submitted in Kazakh.

It is worth mentioning that Kazakhstan is part of the Eurasian Economic Union (EAEU). Among many economic and political areas, the Union regulates and unifies the pharmaceutical and clinical trial industry.

Quality of Clinical Trials

Although there have been no FDA inspections in Kazakhstan, Smooth Drug Development audits of sites in the country show a high level of quality of data produced in the country.

Summary. Clinical Trials in Kazakhstan

There is a nuber of advantages proposed by Kazakhstan in clinical trials:

• Full compliance with the international standards of ICH GCP (Good Clinical Practice).
• Detailed documentation and a focus on accountability and quality indicators allow to obtain data of the highest accuracy.
• A large population. Population can reach 21.5 million by 2030.
• Relatively low accessibility of high-tech methods of diagnosis and treatment for the population, which also improves typing speed and ensures inclusion in the study patients without prior treatment and with different degrees of severity of the process.
• Legislation and the system of organization of clinical research in the Republic of Kazakhstan also make it extremely attractive for clinical research. Term of authorization for conducting clinical studies is up to 3 months.
• The registration`s duration is up to 210 calendar days from the date of acceptance of the application for state registration prior to the issuance of the registration certificate.
• Cost of state registration of medicines (excluding the cost of conducting a clinical study) is much lower than in the US and Europe, about 3, 000 U.S. dollars.
• High qualification of clinical researchers in the field of clinical trials allows to obtain data of excellent quality. More than 60% of clinical researchers are PhDs, about 40% teach at major universities.
• Experience and education of physicians conducting clinical research, allow to obtain data of excellent quality, which is confirmed by inspections by regulatory authorities.
• The potential to reduce the budget of the clinical trial;
• Inclsuion of patients from Kazakhstan in phase II-III trials might accellerate marketing authorisation in EAEU region (Russia, Kazakstan, Belarus, Armenia, etc.)