Clinical Trials in Kazakhstan – Country Profile for 2022

There are many benefits to conducting clinical research in Kazakhstan, its strategic location being one of them. Kazakhstan is a transcontinental country located between Europe and Central Asia; it’s health demographics draw influence from both continents. This is one reason why more and more healthcare organizations are becoming interested in this nation as a venue for conducting their clinical studies.

Cromos Pharma began its operations in Kazakhstan in 2017. Our contract research organization, headquartered in the United States, initially conducted Phase III trials in Kazakhstan, and then proceeded to expand the scope of its medical studies in the region.

Country Overview

According to the latest World Bank data, the Republic of Kazakhstan has a total population of approximately 19 million people, growing at a rate of 1.3% per annum. The main population of Kazakhstan is Kazakhs, one of the Turkic peoples of Central Asia. According to Kazakhstan’s Statistics Committee, about 11.5 million Kazakhs currently reside in Kazakhstan. The capital of the country is Astana. Other principal cities are Almaty, Karaganda, Pavlodar, Aktobe, Atyrau, and Shymkent. 

Kazakhstan is situated in a geographically opportune location, allowing the nation to establish strong diplomatic ties with both its European and Asian neighbors. Kazakh is the official language, and Russian is the language of international communication. Tenge (KZT) is the national currency. 

Health and Pharmaceutical Industry Overview

• Kazakhstan is a relatively youthful country with only 7.9 percent of the population being 65 years or older. The median age in Kazakhstan 30.9 years. The largest age group is 25-54 years old, which makes up 42.3 percent of the populous, making.  The average life expectancy in Kazakhstan is 71 years.
• While the pharmaceutical industry in the country only accounts for 0.45% of its GDP, the sector has grown by 47% during 2021, and is projected to continue expanding at a similar rate in the subsequent years. 

The State of the Healthcare Sector in Kazakhstan

A recent report published in the International Journal of Environmental Research and Public Health, discusses several aspects of the health status of Kazakhstan’s population as of 2021. According to the report, the leading causes of death in adults include ischemic heart disease, stroke, and chronic obstructive pulmonary disease.

The report also concludes that  Kazakhstan lags behind other OECD countries when it comes to its health care system but reassures readers that significant investments in the public health sector are consistently being made. Financial support from the government and private investors will improve the quality of public hospitals in the coming years, both in major cities and in rural areas. The report underlines that Kazakhstan is on its way to being a key contestant in the clinical research arena. With a bigger healthcare budget, and more systemic reforms, Kazakhstan’s goals of increasing life expectancy and decreasing mortality rates are seemingly within reach. Kazakhstan’s investment into its medical infrastructure creates a favorable environment for running clinical trials.

Why Conduct Clinical Trials in Kazakhstan?

Kazakhstan is an emerging clinical trial location, conducting the first international clinical trial on its territory in 2009. The way in which Kazakhstan’s healthcare sector has developed over the last 20 years is truly remarkable. The rapid modernization of the healthcare system and medical facilities after the fall of the Soviet Union has attracted key players in the pharmaceutical industry, such as Roche, Bayer, and Merck, among others. In the last three years, the interest in Kazakhstan and the number of completed and ongoing clinical trials have been growing exponentially. This diverse and fast-evolving nation is quickly becoming a formattable player in the groundbreaking medical research.

Brief List of Benefits to Conducting Clinical Trials in Kazakhstan

• Treatment-naïve and ethnically diverse patient population motivated to find a higher standard of care
• Low number of studies per patient
• Moderate investigator fees
• State-sponsored healthcare that lowers the financial burden for the Sponsor
• Most of the population is concentrated in major cities, where the sites are usually well-equipped healthcare centers
• Local insurance is not required if the global insurance includes Kazakhstan

Patient Recruitment Potential

Kazakhstan has a beneficial competitive landscape for clinical trials, with a population of more than 19 million people. There are currently 52 ongoing trials, which is still a low number, and which creates a significant potential for rapid recruitment in future studies.

Kazakhstan’s healthcare system was developed on the Soviet model, which focused on the early transition to specialized care, paying less attention to preventive services and the primary care sector, thus Kazakhstan could be considered as a potential location for the investigation of treatment-naïve patients, and patients with advanced stages of diseases, since the prevalence of such patients is wider in comparison to European countries.

The MOH of Kazakhstan has identified clinical trials sector a key strategic priority and has put in a lot of effort towards its development. The Kazakhstan MOH has established partnerships with key members of the pharmaceutical industry, digitalized the healthcare system, attracted resources to accelerate innovation,  and is localizing the manufacturing of strategic pharmaceutical products.

The established Kazakh Digitalizing Program simplifies the work of healthcare professionals by providing them with a database containing patients’ medical information, thus allowing doctors to access patients’ medical history more efficiently. Another benefit of this program is the eGovernment Portal, which gives patients the ability to book appointments and access their medical information online.

Skilled and Qualified Clinical Workforce

Kazakhstan fares better than its neighbors – such as China, Uzbekistan and Mongolia – in terms of per capita number of physicians and hospital beds. Additionally, local doctors and health care professionals are trained to uphold competence in their services. A 2020 “Patient satisfaction in Kazakhstan” survey reports that 90.8% of patients are satisfied with their primary care experience.

Good Health Infrastructure and Medical Equipment

The government’s decision to execute the State Program for the Development of Healthcare 2020-2025 benefited the overall healthcare infrastructure of Kazakhstan. Modern buildings, hospital beds, and other health-related needs have become available to the entire population.

A Snapshot of Clinical Trials in Kazakhstan

In total 52 clinical trials are now being conducted in Kazakhstan according to data obtained from clinicaltrials.gov. The largest share is in the field of infectious diseases (13), followed by pulmonology (5), oncology (5) and cardiology (5). Local Sponsors are responsible for 54% of ongoing trials.

RA/EC Approval & Start-Up Timelines

Regulatory Protocols Worth Noting

Initiation of clinical trials in Kazakhstan requires the submission of trial-related documents to the National Center for Expertise of Medicines, Medical Devices, and Medical Equipment. The set of documents to be submitted should include the clinical trial protocol, the investigator’s brochure, and an informed consent form, to name a few. The list of all the documents can be found on the website of the said governmental authority.

The National Center then performs a pre-assessment of the application. Pre-approved proposals need to be forwarded to the RCHD – the Central Ethics Commission. This step ensures that the medical research to be performed meets and observes the highest standards for health care ethics. Revisions may be required depending on the evaluators’ judgment.

The final decision to approve the Clinical Trial Application comes from the Kazakhstan’s Ministry of Healthcare. On average, the entire process takes around 20 weeks, from document submission to final approval.

Cromos Pharma in Kazakhstan

Cromos Pharma has an experienced local team that effectively manages regulatory and contracting processes to ensure that studies can be initiated in the shortest amount of time possible. We recruit highly educated and experienced staff that assures that each trial managed by our team in Kazakhstan produces exceptional data quality and reliable results.

Summary

Kazakhstan continues to improve various facets of its public healthcare system. The government is very supportive of the clinical trials, modifying policies, and providing assistance to its residents who are willing to volunteer and take part in clinical research. With constant development and continuous investments, Kazakhstan is bound to become one of the most important locations for clinical trials in Central Asia.