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European Pharmaceutical Contractor

Putting Kazakhstan on the Clinical Trials Map

Anna Ravdel and Irina Kim of Synergy Research Group share some advantages of conducting clinical studies in Kazakhstan as well as some crucial aspects for companies to consider

Increasingly, Western pharmaceutical and biotechnology companies have begun to explore other countries for clinical trials. Some 15 to 20 years ago, only a few companies were brave enough to conduct clinical trials in Russia, attracted by high enrolment rates, however, the numbers are expanding almost daily. Nowadays, Russia is a traditional player and companies continue to explore new horizons in an attempt to increase enrolment and shorten the time it takes from labs to market. Other former USSR countries have entered the game, including Kazakhstan, a large country with great potential for clinical trials. This article will give a short overview of the different aspects of conducting clinical trials in Kazakhstan.

As Kazakhstan will be new territory for most clinical trial professionals considering conducting research here, some general facts about the region should be highlighted. The Republic of Kazakhstan is a state located in Eurasia that shares borders with Russia, China, Kyrgyzstan, Uzbekistan and Turkmenistan. Ranked as the ninth largest country in the world, its territory of 2,727,300km2 is greater than the whole of Western Europe. Kazakhstan is not a heavily populated area; its population is around 16 million, with a density of less than six people per square kilometre. Kazakhstan is ethnically diverse, with two national majorities – Kazakhs (about 63 per cent) and Russians (about 23 per cent). The remaining 14 per cent is divided between more than 100 nations. Kazakh is the official language, but Russian is equally popular in state institutions and local selfadministrative bodies.

HEALTHCARE SYSTEM

Kazakhstan’s healthcare system is fairly centralised, with 80 per cent of medical institutions owned by the state. There are about 1,000 hospitals in Kazakhstan, almost 4,000 outpatient clinics with about 120,000 beds and altogether around 60,000 physicians practicing. Personal healthcare in Kazakhstan is financed from three sources: state budget, medical insurance and payment by patient.

The state covers treatment of certain diseases and drugs (under generic names) in accordance with a list approved by the Government. Medical insurance is not required by law, and in a lot of cases is issued by employers, although partaking in such schemes is not compulsory, meaning many individuals are not covered. If a certain treatment or drug is not paid for from either of these first sources, patients have to pay for it themselves.

PHARMACEUTICAL MARKET

According to various estimates, the market value of medicinal products in Kazakhstan is about $1 billion, of which 40 per cent is bought by the government within a framework of guaranteed medical care, and 60 per cent is bought by commercial organisations. Between 90 to 95 per cent of the products are imported from different countries; the largest importers are Russia, the US, Germany and France. The market value of medical devices is smaller (about $115 million per year) with the market share of imported products standing at approximately 90 per cent. More than 100 representative offices of foreign pharmaceutical companies are currently working in Kazakhstan.

CLINICAL STUDIES

Clinical studies in Kazakhstan are regulated by certain laws, instructions and orders, including:

  • The drug law of 13 January 2004
  • Order No 744 of the Ministry of Health, ‘Approval of the instruction of the conduct of clinical trials of pharmacological and medicinal products in the Republic of Kazakhstan’ of 19 November 2009
  • The state standard ‘Good Clinical Practice’ of 29 December 2006
  • Order No 710 of the Ministry of Health, ‘Approval of the instruction of the imports and exports of drugs, medical technology’ of 16 November 2009
  • Order No 425 of the Ministry of Health, ‘Creation of Central Ethic Committee’ of 30 July 2008
  • Code of People’s Health and Healthcare System of 19 September 2009

GCP-regulated clinical studies began in Kazakhstan between 2006 and 2007 after the adaptation of Order No 53 and the Good Clinical Practice standard. About 70 per cent of the studies conducted in Kazakhstan are observational and noninterventional, though lately the number of interventional studies has begun to increase.

START-UP PERIOD IN KAZAKHSTAN

One of the most important factors in clinical trial conduct is the start-up period: protractions during this period can cause serious delays to the overall study and corporate deadlines might not be met. If a country’s feasibility assessment (including considering the regulatory and logistics aspects) is not performed properly and carefully, study approval can be granted very late. All possible regulatory concerns, questions on clinical trial materials handling and so on should be taken into consideration while making the decision to go into a new country. Based on this, these are various crucial aspects to be considered when planning the study start-up period in Kazakhstan.

In order to begin a clinical study in Kazakhstan, a submission should be made to the National Center of Drug Expertise (NCDE, under the Department of the Ministry of Health). Such a submission can be carried out either by the sponsor, or by the CRO; in the latter case the sponsor should issue a delegation of authority. The submission package includes documents which require translation; both the study protocol and investigator brochure are submitted in English and Russian and all the documents which are distributed to patients (informed consent forms, patient information sheets, questionnaires and so on) should be in both Kazakh and Russian. Also, as in other CIS countries, in addition to the general sponsor’s insurance, local insurance should be obtained before the package submission. After the NCDE’s approval, documents are submitted to the Central Ethics Committee (CEC). If the CEC gives a positive opinion of the study, a draft study approval is issued, and a second submission to NCDE is required. The Ministry of Health gives final study approval based on NCDE approval and CEC positive opinion. Altogether, the approval process takes about three to four months.

When general study approval is obtained, a new stage of the start-up process begins:

  • Local ethics committees should either approve the study or be informed about the study (depending on the protocol)
  • Clinical trial agreements with participating sites and investigators should be signed
  • The sponsor or CRO should receive the importation approval for clinical trial materials (investigational product, laboratory kits, medical devices and so on). An import license for the investigational product is obtained from the Ministry of Health and is granted only to a local entity (the sponsor, a local subsidiary or the CRO); import permits for other clinical trial materials are obtained from the Committee for Pharmacological Supervision
  • For export of bio-samples during the study, an export license should be obtained

In general there are two ways of handling the clinical trial materials (CTMs): centralised handling (where all CTMs are imported into one depot, stored and then distributed to the sites according to the recruitment needs), and decentralised handling (separate import shipments are performed from the manufacturing/ packaging facility to the sites). In Kazakhstan it is only possible to execute the centralised approach, which is both timely and cost-effective.

In order to avoid delays in CTM importation, it is important to follow some simple rules:

  • The courier company and method of transportation should be discussed and agreed upon with local professionals
  • A proforma invoice should be approved by a customs broker (or CRO if the CRO performs the customs clearance) prior to each shipment

Bio-samples can be exported depending on the situation, either using the decentralised approach (shipment from each site to the central lab) or the centralised approach (shipment to local depot and then bulk shipments to the central lab). The latter method of exportation is usually applicable for frozen samples only.

A go/no-go decision does not only depend on regulatory information – the sponsor has to be sure that there are enough potential patients to participate in the study. Of course, local professionals will conduct a feasibility study to assess enrolment potential; however, it is also important to know that Kazakhstan possesses epidemiology statistics, which allows feasibility studies to be performed quickly to check the suitability of the county in general. For some diseases, this epidemiology information is also divided by region.

It is important to be aware that, in order to participate in clinical trials, investigator sites require accreditation and so during feasibility assessment one should check if the potential site has such an accreditation. Nevertheless, it is possible to obtain a oneoff approval to participate in a particular project, so sites without upfront accreditation are also entitled to be part of the studies.

STUDY CONDUCT

Technically, the study conduct phase in Kazakhstan does not differ much from that in other countries. However, it is worth mentioning that, as in any other country, Kazakhstan has both strengths and weaknesses in relation to clinical trials performance.

Among the weak points, it should be noted that, since it is a relatively a new territory for clinical trials, Kazakhstan has few investigators with experience in Phase I-III trials, and the overall command of English among investigators is not high. Most studies in Kazakhstan are conducted using paper CRFs; in order to conduct an EDC study, investigators should be provided with computers, and the internet connection should be paid for separately. As investigators are not very experienced, they may require considerable training and closer followup than in other countries. Overall, Kazakhstan’s weaknesses are the same as those faced by other CEE/CIS countries at the beginning of their clinical trials career, and these in time have largely been overcome.

Kazakhstan’s Strengths
The advantages of Kazakhstan as a trial location are not new for companies going east to conduct their studies. One main strength is the high enrolment potential due to the following reasons:

  • Free healthcare coverage is insufficient (as mentioned above, not all the aspects are covered by state medicine and health insurance), so patients are motivated to participate in clinical trials as this gives them the opportunity to receive free treatment
  • There is a large pool of treatment-naïve patients
  • The multi-national population is good for clinical trials
  • There are almost no competing studies
  • Patient compliance is very high (traditional for CIS countries)
  • Investigators are motivated in clinical studies participation both for scientific/cultural and financial reasons

There are other advantages of the region; though not particularly experienced in clinical studies, investigators are usually highly educated physicians. Doctors complete CRFs by themselves, and this contributes to the quality of CRF completion. In addition, the Kazakh medical system is still very centralised, so clinical studies will be conducted in large medical centres specialising in certain therapeutic areas. It is also worth mentioning that investigator grants are smaller than in the countries with a lot of experienced investigators (both Western and Eastern Europe, including Russia and Ukraine).

CONCLUSION

Although the borders of today’s clinical trials map are expanding, there are still countries with untapped high recruitment potential, of which Kazakhstan is a prime example. Despite a lack of experience in clinical trials in the region, as well as some other peculiarities which can be a source of uncertainty in making a decision on where to initiate a study, accurate study planning – including a feasibility assessment, and proper preparation and start-up periods, along with the intense training and close site management – will decrease (if not eliminate) the risks involved with conducting studies in this country. Adding Kazakhstan to the clinical trials world map will address the increasing need for pharmaceutical companies to conduct studies quickly while achieving high quality data.


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Anna Ravdel is Director of Business Development at Synergy Research Group (SynRG). Anna graduated from the University of Manchester with an MBA degree in 2001. She became familiar with the CIS regulatory environment during her work as a Director of Business Development at both Evidence Clinical and Pharmaceutical Research and at Worldwide Clinical Trials, where she was employed prior to joining SynRG in June 2009. At her current position, Anna works with the operational departments and is in charge of the overall clients’ proposals development.

Irina Kim is a Director of the Kazakhstan branch of Synergy Research Group and has a deep knowledge of the regulatory processes in the region. Irina graduated from the Kazakh Medical University and received a degree in Internal Medicine at the Moscow Medical Academy. She has over 10 years of experience as an assistant professor in the Department of Postgraduate Training at the Kazakh Institute of Postgraduate Education. Irina has been working in the clinical trials field since 2007 and has extensive experience in working with the regulatory agencies in Kazakhstan.

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