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International Clinical Trials

Fertile Ground

With its experienced investigators, large patient pool, wide medical coverage and excellent location, Ukraine is increasingly viewed as a preferred region for conducting clinical trials in oncology, as Andrei Kravchenko of Harrison Clinical Research discusses

Ukraine is a distinctive country with a long history and recently acquired independence; a country with great opportunities for business innovation, including medical and scientific research. The business environment in Ukraine has changed significantly over recent years, making the country much more attractive for pharmaceutical companies performing clinical research. Ukraine is also one of the most populated central and eastern European countries (CEE), and with more than 46 million inhabitants is second among the CEE after Russia. Approximately 30 million Ukrainians live in urban areas; this centralisation facilitates access to medical care and hence eases the recruitment of subjects for clinical trials.

Historically, the healthcare system in Ukraine has a vertical referral scheme, meaning that the selection of patients for clinical trials can be coordinated centrally. Also, patients are often referred from small cities to big centres for detailed diagnostics and treatment, with the majority of oncology sites located at these large centres.

Another relevant feature of Ukraine’s healthcare system is the approach to routine screening and prophylaxis activities. These types of activities help to identify subjects with earlier stages of certain diseases (such as newly diagnosed cancer patients). However, despite routine screening, the rate of untreated or late-stage cancer is still very high. The most obvious explanation for this is that many people do not go to physicians until their disease has progressed. In general, the prevalence of untreated populations is much higher than in western Europe or the US, which opens a lot of possibilities for clinical research. Therefore, one of the better options for cancer patients is to participate in clinical trials, especially in cases where the sponsor provides the baseline therapy in addition to the investigational medicinal product.

ONCOLOGY SERVICE

Specialised oncology care in Ukraine is organised in a system for diagnosing cancer diseases (including screening measures), treatment and rehabilitation of cancer patients. The basic principle of this specialised care is the mass health examination (also called the dispensary method). It plays an important practical role for the general population because it reveals oncology diseases and keeps statistics in oncology up-to-date.

The administration of the whole oncology service in Ukraine is subordinated to the Ministry of Health, and scientific leadership for all oncology institutions is provided by a governmental institution, the Ukrainian Research Institute of Oncology of the Academy of Medical Science of Ukraine, which serves as a national cancer institute for the country. This institution is also the physical base of the Ukrainian Cancer Registry (the national cancer register). The network of oncology care includes specialised oncology institutes, 46 oncology dispensaries, as well as many oncology departments and centres. Regional oncology units in the polyclinics work within this structure as the first line of oncology care in Ukraine. All types of specialised oncology care establishments (with the exception of regional oncology units) represent clinics where sites involved in clinical trials are located. In Ukraine, the state system of cancer registration has been functioning since 1932. The process of cancer registration can be described as follows:

  • When a new case of cancer is identified or even suspected, the corresponding general practitioner fills in a special notification form (‘Notification of patient with cancer or other malignant neoplasm established for the first time’) and forwards it to the oncology dispensary within the territory of the patient’s residence. Dispensaries are located in each province (oblast) of Ukraine. In total, 25 dispensaries serve Ukrainian citizens
  • In the dispensary, the notifications are checked and duplicates are excluded. The identified patient can be invited for examination. If the malignant diagnosis is confirmed, the ‘Registration Card for a patient with malignant neoplasm’ is filled in. Thereafter this form is updated with the information related to the treatment and follow-up of the patient

There are two different levels of registry: the population-based cancer registry and hospital cancer registry. The populationbased cancer registry records information on all cases of the disease, occurring within a certain territory. Collection of this information in each territorial administrative unit is focused in a specialised oncology dispensary. Some large cities and smaller territorial administrative units have their own dispensaries; these cities and smaller units collect information independently and then supply it to dispensaries at a higher administrative level. The network of these different level dispensaries covers the whole of Ukraine.

The hospital cancer registry records information about all oncology patients, having received treatment in a specialised medical establishment, for example an oncology dispensary. This part of the register is more useful for clinical trials as it helps to identify the size of a suitable subject population and particular details (for example, diagnosis, treatment received, outcomes and so on). The automated package for hospital cancer registry is currently in operation in 11 oncology dispensaries of Ukraine. In total they contain information on over 150,000 patients; the Ukrainian Research Institute of Oncology and Radiology stores information on over 70,000 patients who received treatment in the institute clinic since 1985 or, for certain types of diseases, since 1969.

The healthcare service in Ukraine was built with the aim of providing a service free of charge for the population and it is still sponsored by the State. Therefore the most expensive medications can not always be covered by the state budget. An absence of obligatory medical insurance leads to an impossibility for uninsured patients to obtain the newest medications. Obviously, participation in a clinical study is often desired by patients with severe and chronic diseases (like oncology diseases, where approximately 165,000 people are diagnosed every year in Ukraine) as it provides free access to novel drugs and a high standard of care including advanced lab testing, instrumental diagnostics, extensive medical observation and comprehensive in-patient care. Thus, many sponsors of clinical trials select Ukraine for projects where high speed recruitment is essential.

Such selection is understandable; note for example the similarity between such parameters as morbidity (and mortality) in Ukraine and those in developed countries, where cardiovascular disease is the leading cause of mortality, followed by tumours (see Figure 1) (1). The structure of clinical trials in Ukraine shows the trend for a prevalence of clinical trials in cardiovascular and oncology followed by respiratory tract diseases (see Figure 2) (2). This trend has continued during recent years (see Figure 3) (2).

Clinical trials in oncology were among the first international multicentre trials conducted in Ukraine. From the beginning, the proportion of clinical trials in oncology was very significant within the overall breadth of clinical trials conducted in the country. Such experience explains the high quality of work and good results of audits conducted at Ukrainian oncology trial sites during the last decade. It is also important to mention that the majority of principal investigators performing oncology trials have Professor or Associate Professor status and have a strong scientific background in addition to their high professional level. The opinions of these therapeutic leaders are also important for the scientific assessment of study materials. Competent authorities, the central ethic committee and those key opinion leaders who are not participating in a particular study are often involved in a scientific evaluation of the study as external experts during study authorisation.

PICTURE OF PROGRESS

Due to overall progress in clinical trials in Ukraine, the challenges of early 1990s (for example knowledge of the English language and distribution of responsibilities) have now been overcome. The vast majority of site teams have experience of EDC, and are familiar with various electronic reporting and transmitting systems, which clearly reduces the time and effort needed for study set-up. Experienced sites are already well equipped with apparatus centrifuges, fax lines with international access, high-speed internet, freezers at -20oC, and so on). According to Ukrainian legislation, GCP training for principal investigators and sub-investigators is mandatory for study approval, so the study teams have good knowledge and understanding of GCP requirements (3).

Taking all this into account, oncology sites (some of which have up to 20-45 members) are among the leaders in Ukrainian clinical research and provide good examples of investments made by sites to contribute to multicentre projects. According to current information, there are more than 50 studies in oncology that are currently active in Ukraine (4). More than half of the multicentre clinical studies in oncology over the last decade (2001 to 2011) were conducted in breast, lung, renal cancer and haematological oncology (see Figure 4) (4). This division broadly reflects the oncological morbidity in Ukraine and confirms that Ukraine has a large patient pool for potential oncology clinical trials. The total number of oncology studies listed in http://www.clintrials.gov/ in Ukraine is 153. However, not all the Ukrainian studies are registered in this database and the actual number of oncology clinical trials is higher.

CONCLUSION

Oncology trials represent one of the largest groups of all the clinical trials in Ukraine (2). Taking into account the large patient pool, wide medical coverage, European location, experienced investigators and high recruitment rates, Ukraine is recognised as one of the preferred countries for conducting clinical trials in oncology. Utilisation of available medical resources in Ukraine allows for further growth in the number of clinical trials in this field.

References

  1. www.ukrstat.gov.ua/ cited on 1 March 2011
  2. Kornatskyy VM and Silantieva OV, Ethical aspects of medicinal clinical trials, p264, 2010
  3. Order of the Ministry of Health of Ukraine #690, 23 September 2009
  4. http://www.clintrials.gov/ cited on 10 March 2011

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Andrei Kravchenko, has a PhD in Dermatology and started in the pharmaceutical world as a CRA in 2002. In 2003 he took the position of Clinical Trial Manager. Since 2007 he has held the position of Head of the Ukrainian office of international CRO Harrison Clinical Research. Andrei’s main fields of interest include tailoring solutions in international projects with focus on rescue studies, feasibility processes, crisis management and time-efficient project management. Email: andrei.kravchencko@harrison-cro.com
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