Mon,23Apr2018

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Pan Asian Clinical Research Association (PACRA)

Clinical trials in Kazakhstan

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Igor Stefanov, Irina Kim, CRO "Synergy Research Group"

Before and After

One year ago at an official governmental meeting the Minister of Health of the Republic of Kazakhstan Mr. Birtanov E.A. posed the question "Why are there so few clinical trials in Kazakhstan?" This important question was to become the defining moment that divided the historical development of clinical research in Kazakhstan into "before" and "after".

Theory Into Practice

For the past 5-6 years there have been multiple dialogues involving diverse parties affirming that clinical studies are necessary not only for pharmaceutical manufacturers, but also for patients who don’t have access to modern high-tech medicines, for doctors to receive international medical experience, and in general for the benefit of the country as a whole. It’s now time to put into practice the next steps that will ultimately lead to the removal of any remaining barriers to further clinical research development. Kazakhstan’s efforts to become a full participant in the community of clinical research have therefore not been in vain. Positive changes are taking place now and even more will emerge.

Positive Changes

Firstly, valuable experience has already been acquired from Kazakhstan’s existing participation in international studies. Secondly, there have been positive regulatory developments too, such as the development and improvement to the system of ethical oversight. A number of ethical committees have undergone international accreditation and have developed standard operating procedures detailing their activities, and in the process has reduced the time for conducting ethical reviews of documents from 2-3 months to just 2-3 weeks. Thirdly, Kazakhstan’s leading research institutes, academic and medical institutions have already started to embrace clinical trials with great enthusiasm and understanding.

Eurasian Economic Union

Doctors have a real need for training in internationally recognized and accepted GCP standards, as evidenced by the increased number of inquiries, not only from pharmaceutical companies’ representatives, but also from the heads of institutions and specialists. Since 2015, when Kazakhstan became an active participant in the ‘common market of medicines’ (medical products and medical equipment within the EAEU), there have been positive changes. Now studies conducted within the territory of one of the EAEU countries will be accepted by all other EAEU members. We believe that Kazakhstan has all the conditions in place to fulfil the EAEU requirements.

Regulatory Update

Dedicated work is already under way to improve the regulatory environment. A draft of an updated regulation on the rules for conducting clinical trials in Kazakhstan is in the process of final approval. Previously only Phase III and IV studies were allowed to be conducted, whereas now the new regulations will allow for the conduct of Phase I-IV trials, as well as pediatric studies. The time to obtain approval for interventional studies will also be substantially reduced. The period of expert review will now be no more than 40 days, starting from the moment of the signing of the contract with the expert organization until the final decision is received from the authorized body. Thus, in general, from the moment of the submission of documents for examination to the opening of a center should be no more than 2 months. This is an excellent example of the significant progress that has been made when one compares this with the previous timelines of 6-8 months.

Remaining Challenges

Of course, one shouldn’t ignore the fact that there are still some existing issues. First of all, the existing heavy workload of investigators within their primary work environment may affect the pace of recruitment. In addition, not all nosologies have qualitative registers and statistical data that can be used to proactively engage patients. We are currently focusing our efforts in this direction, and we hope that in the near future we will start to see practical results. In Kazakhstan, for the purpose of digital modernization of health care and transition to a paperless format of work, hospital information systems (HIS) are continuously being introduced. Currently 45% of healthcare organizations are already covered by these digitalized systems, and by the end of the 2017 this percentage should increase to 64%. The anticipated reduction in the volume of paper documentation should free up some valuable time resource for investigators. Today a brand new generation of physicians is emerging in Kazakhstan who have the opportunity to receive valuable education and training in international institutes, master modern IT technologies, and improve their English and other foreign languages. With the emergence of these new clinical research torch bearers we will not only contribute to the future development of our country, but also to the future development of clinical research...

Philip Lafleur, Assistant Professor of Practice, Director of Center for Clinical Trials  Nazarbayev University School of Medicine

This is the third in a series of articles about the growing potential for clinical trials in Kazakhstan with contributions from the Nazarbayev University School of Medicine and Synergy CRO. Part I can be found here.

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