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International Clinical Trials

Ukraine Calling

In terms of a country’s attractiveness to the R&D life sciences industry for clinical trials, there is a golden period between the time that the infrastructure, systems and capabilities are in place to provide high-quality output and the time when competition for patients makes recruitment difficult. Ukraine is right now in that ‘sweet spot’ between emerging on the scene and being saturated with trials.

Ukraine adheres to internationally recognised guidelines, and offers highly-qualified medical personnel and two decades of experience in running international clinical trials. Yet it still affords easy access to patients, producing typically strong recruitment rates, with an overall per-patient cost that is less than in Western Europe. These are compelling reasons for clinical trial sponsors to consider Ukraine as an efficient and productive location for carrying out their trials.

On the Map

Ukraine is located in Eastern Europe and borders Russia, Moldova, Romania, Hungary, Slovakia and Poland. In terms of area, it is Europe’s second largest country and is slightly smaller than the US state of Texas. At 45.5 million, the country’s population is on par with Spain (47.3 million) and double that of New York state. The capital, Kiev, has a population of 2.8 million, and other large urban areas include Kharkov, Dnepropetrovsk, Odessa, Lvov, Donetsk and Zaporozhye. Nearly 20 per cent of the population resides in these seven cities and 60 per cent lives in urban areas.

In 1991, Ukraine became an independent republic, having declared its independence from the Soviet Union.

It is a participating, non-member of the Commonwealth of Independent States (CIS), and is governed by a president, prime minister and parliament. While the country is not yet part of the European Union (EU), it has declared its adherence to EU values and a willingness to join the Union in the future. To do so, it must align its legislation with the EU’s; indeed, in most areas related to clinical trials, it has already done so.

Healthcare System

Ukraine’s healthcare system can be described as ‘in transition’, with a growing market for modern treatments. Healthcare is provided through a state-run system of outpatient facilities and general practitioners, general hospitals for secondary care and large, specialised university hospitals for tertiary care.

Since the system is very centralised, the referral network between practitioners is strong and effective. The constitution provides for free, universal healthcare for all, which is funded by the citizens’ social security contributions.

However, the government's facilities and diagnostic capabilities are not always state-of-the-art, and the standard of care provided often does not include the most advanced treatments and frequently requires long waiting times. Consequently, many patients seek treatment at better equipped private institutions, where they must cover the costs themselves. To support this practice, private health insurance is on the rise.

Clinical Facilities

The current structure of the healthcare system in Ukraine facilitates patient recruitment for trials, and existing healthcare practices make for enthusiastic investigators and willing subjects.

Compared to the US or Western European countries, Ukraine has relatively fewer but larger tertiary care facilities, and they each contain selected speciality clinics. Thus, the clinic for a given condition tends to be located within a regional facility, rather than replicated at each general hospital.

This facilitates the identification and recruitment of trial subjects, as patients are concentrated within fewer facilities.

Because the standard of care within the socialised healthcare system has not always included the latest, most advanced treatment, it is relatively easy to still find patients who are modern-treatment-naïve. Indeed, patients generally view clinical trials as an opportunity to take advantage of more advanced diagnostic techniques and breakthrough treatments.

Study Environment

Physicians within Ukraine, too, are generally eager to participate in clinical research, and their experience as investigators has grown dramatically in the past decade (see Figure 1, page 28). Clinical staff typically have a good command of English – particularly in writing – and documents do not normally need to be translated for investigators. However, materials for patients need to be translated into Ukrainian and Russian. Ukraine also has 35.2 physicians per 10,000 people, compared to 24.2 in the US.

All that said, Ukraine is not particularly well-suited or amenable to first-in-man studies. Few facilities have the appropriate staff and equipment, and there is a general reluctance by the regulatory authorities to allow Ukrainians to be subjected to early-stage experimentation.

The degree to which Ukraine offers untapped potential can be seen in a comparison with Spain. Spain’s population of 47.3 million supported 745 clinical trials in 2012; Ukraine’s population of 45.5 million supported just 213 the same year.

Application Process

The Clinical Trials Coordination Department of the State Expert Centre of the Ministry of Health (MoH) has established clinical trial regulations similar to those in other countries. The centre has recently reorganised, creating a department to focus exclusively on trial applications and material reviews (see Figure 2).

Ukraine’s clinical trial regulations have been created with the aim of being in harmony with the directives, guidelines and bylaws of the EU, and in compliance with the Declaration of Helsinki and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use Guidelines for Good Clinical Practice. The country’s laws surrounding clinical trials are widely recognised as among the most advanced of CIS and other Eastern European nations.

The process for seeking approval to conduct a clinical trial in Ukraine is quite straightforward, closely paralleling EU standards. Applications must be submitted both to the State Expert Centre of the MoH (the regulatory authority) and to the Local Ethics Committees (LECs) at each investigational site. These applications may be submitted simultaneously, which shortens the general start-up period. Contracts with investigators and sites need not be in place at the time of application submission and are normally completed while waiting for regulatory approval.

The LECs require fewer documents than the regulatory authority, which stipulates an investigational medicines product dossier (IMPD) just as is needed throughout the EU. Ukraine is the only non-EU country that requires this, so it may take some sponsors by surprise. Translations into Ukrainian or Russian are required for some documents, such as the letter of delegation, the patient information and consent form, the patient’s diary and labels, similar to many other countries. This can be accomplished within the typical dossier preparation timeline.

Regulatory Approval

The regulatory authority is required by law to respond within 60 days to the application; LECs are given 30 days. In Ukraine, as in many countries, this timeline is aspirational and does not always bear out in actual practice. Experience has shown that regulatory authority approval generally takes 9-10 weeks and LEC approval four weeks. Again, these two tracks can run simultaneously and need not be sequential.

Either reviewing body can ask the sponsor for more information or for clarification during any point in the review. When this happens, the ‘clock stops’ until the sponsor’s response is received, at which point the countdown to the approval deadline resumes.

Unlike in some countries, these exchanges continue until the agency is satisfied that it has all the information it needs, and recurring requests do not automatically lead to denial of the application (in some countries, applications are automatically denied if a sponsor’s first response is deemed inadequate). Following regulatory approval of the trial application, sponsors must apply for an import/export licence.

The total start-up period generally takes about 18 weeks – roughly the same as in some EU countries (see Figure 3).

Study Conduct and Data Quality

There is no list of sites approved for clinical trial participation in Ukraine; all investigators and healthcare settings are free to take part in clinical trials if they meet the country’s regulations. The State Expert Centre conducts regular Good Clinical Practice training sessions for investigators, and regulates contracts between sponsors/contract research organisations and investigators, hospitals and institutions.

Ukraine has earned a reputation for conducting high quality studies that follow the protocol and abide by regulations. Certainly, the results of US Food and Drug Administration (FDA) audits have helped to secure that status. From 2009 to 2012, the FDA conducted 35 inspections of trial sites in the Ukraine. Of these, 10 produced voluntary action indicated results; the remainder received no action indicated results and there were no official actions indicated. While the total number of FDA inspections makes any direct comparison to results in the US inequitable, there is a clear trend indicating that studies in the Ukraine are done properly, guaranteeing patient safety and good quality data.

Rich Opportunity

Ukraine, while certainly not undiscovered by drug sponsors, remains a country rich with opportunities for running clinical trials and one well worth considering. Its easily reachable, modern-treatment-naïve population results in strong recruitment rates. And its eager, well-trained investigators and practices that conform to international standards produce good-quality results.

Sponsors interested in Ukraine should, of course, work closely with an organisation that has a physical presence in the country and a thorough understanding of where requirements may be unique.


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About the author

Dr Pavle Vukojevic is Vice President, Medical Affairs at Pharm-Olam International and has been involved in clinical research for over 20 years. As the Regional Director of Operations, he was responsible for opening the company’s representative offices in multiple CEE countries. Pavle is one of the founders of the Association of Clinical Research Professionals in Serbia and was Chapter President until 2008. He has also authored numerous expert reports.

Oleksandr Iaroshkevych is an Associate Director, Project Management at MB Quest, a division of Pharm-Olam International. He is an MD and PhD with nearly 15 years of clinical research experience, ten of which have been specialised in project management. Oleksandr has worked in a number of therapeutic areas in different stages of clinical trial programmes across all continents.

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Dr Pavle Vukojevic
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Oleksandr Iaroshkevych
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