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International Clinical Trials

Growth Market

Suzanne Pozsonyi of SynCon International surveys the clinical research scene in Hungary and concludes what formula makes it such a popular location for running studies

The number of clinical trials conducted in central and eastern Europe (CEE) has seen impressive growth over the last 20 years. Centerwatch provides a comparison of the numbers of total clinical trials initiated over this period in some selected CEE/EE countries (see Figure 1) (1). Hungary is one of the key players in the CEE region, and this article will assess the country’s current status, and what it has to offer.

HUNGARIAN SITUATION

GCP clinical research began in Hungary in the early 1990s and has gone through a radical development since then. As of 2011, around 300 clinical trials are initiated yearly in Hungary – an outstanding number, considering Hungary’s population of 10 million. The developments that have taken place, plus the huge experience gained by investigators, patients and service providers, has meant that Hungary is seen as an even more attractive venue for clinical trials.

A number of factors in particular have played a role in cementing this growth:

Access to Patients

A critical factor for the success of clinical trials is the access to special patient populations, patients with diseases of higher incidence, and treatment-naive patients. The Hungarian population has endemic health problems:

  • The occurrence of hypertension complications, cerebrovascular disease and ischaemic heart disease is high, with the latter representing the dominant cause of death in Hungary
  • Approximately 4.6 per cent of the population is affected by diabetes
  • The number of patients with pulmonary condition other then TB has more then doubled during the last 20 years
  • Tumours represent a main category of disease, as around 65,000 new malignant tumours are detected each year
  • Among diseases of the digestive system, stomach ulcers and duodenal ulcers are common, and the prevalence of chronic liver disease is high
  • In terms of diseases of the locomotor system, osteoporosis and rheumatic arthritis occur in around 900,000 and 100,000 patients over the age of 50 years respectively within the Hungarian population. The bone density figures of the Hungarian population are the lowest in Europe and the consequential fracture of the vertebrae present one of the highest numbers in the region

The primary most frequent therapeutic areas included in clinical studies since 1990 are shown in Figure 2. The combination of free access to modern therapies, plus the excellent medical equipment and professionals on offer means that patients are keen to participate.

Moreover, with the increase of clinical trials in Hungary, patients have become more knowledgeable about clinical trials, fuelled by initiatives from patient associations and the European Union-funded Patient Partner Project. The aim of this project was to identify the patients’ needs for partnership in the clinical trials’ context – and several workshops were also held in Budapest. In the context of European Patients’ Academy on Therapeutic Innovation (EUPATI) – a project funded by the Innovative Medicines Initiative (IMI), which is a joint undertaking of the European Commission and the pharmaceutical industry – the knowledge of patients about clinical trials and the options for an active role in clinical trial planning and performance will certainly substantially increase in the coming years.

Healthcare Structure

The healthcare structure in Hungary has been centralised – a legacy from the former centralised economic system after World War II. With the reforms of the present government, healthcare will be restructured, as outlined in the Semmelweis Plan (2). The objective is to raise the efficiency of healthcare through, for example, the rationalisation of hospital care and healthcare services.

With this goal in mind, 12 municipal hospitals are being taken back under central government authority. Nine regional health centres, each catering for one to 1.5 million people, is also envisioned in this plan.

Alongside major municipal hospitals, university centres like Budapest, Szeged, Pécs, Debrecen and major cities play an important role in attracting patients.

The distribution of the total number of clinical trials among the major cities of Hungary over the last two decades is shown in Figure 3 and Table 2.

Figure 3 reiterates the significance of the capital, Budapest, from a clinical trial perspective, where the majority of the trials take place. The city’s population density, along with the presence of a major medical university, municipal hospitals, and national institutes specialising in therapeutic areas means most trials take place in Budapest.

According to Hungarian regulations, Phase 1 studies may only be conducted at accredited Phase 1 units. This accreditation is granted by the Hungarian drug authority, The National Institute for Quality and Organisational Development in Healthcare and Medicines – the GYEMSZI – (the former OGYI is integrated into GYEMSZI). These Phase 1 units can be found at regional municipality hospitals (Budapest Polyclinic of the Hospitaller Brothers of St John of God), and medical university clinics such as Budapest, Debrecen, Szeged and Pécs, and at national institutes (National Institute of Oncology, Budapest) or private clinics (DRC Balatonfüred, Pierrell Clinical Research Units, PRA Pharmacology Unit) (3).

Aside from major urban centres, there are various national institutes that specialise in therapeutic areas, such as cardiology, oncology, rheumatology, pulmonology, and so on. These institutes are well-equipped to carry out major amount of clinical trials (4). There are also private clinical centres, who contribute to clinical research by offering special focused patient populations (5).

Investigators

Hungary has a strong tradition of supplying qualified researchers in the life sciences, biotechnology and bioinformatics field. There are 10 large universities offering life sciences-related tertiary education, with close to 25,000 students, 3,000 post-graduates and 1,000 PhD students each year. The medical universities of Budapest and Pécs (Southern Transdanubia Region), Szeged (Southern Great Plain) and Debrecen (Northern Great Plain), are standout establishments, widely recognised as leading centres for medicine and health sciences. Hungarian medical doctors are well-educated, and offer tremendous experience based on a good compliance in record.

The growing number of trials based in Hungary led to the increase in FDA activity; the result of the FDA audits performed at Hungarian investigators sites are shown in Figure 4. This result in fact mirrors the entire CEE region; only voluntary actions as opposed to mandatory steps were required by the FDA.

Training of Clinical Research

Professionals According to the Hungarian authorities’ requirement, an investigator must hold a GCP training course certificate from within the last five years. These investigators also should attend regular follow-up training sessions, organised by pharma or CRO companies, or professional associations.

Recognising the need for highly educated professionals, the University of Miskolc and the Hungarian Clinical Trial Management Society offer training. This course lasts two semesters, the students must write a thesis, and the course ends with an examination. The trainees receive a diploma accredited by Miskolc University.

Association of Clinical Research Professionals

Clinical Trial Management Society (CTMS – MKVT ) founded in Hungary in 2001 is a self-governed organisation, whose members are professionals in the field of organising, conducting, controlling and evaluating clinical trials for human medicines, test preparations and devices. CTMS – MKVT is the fi rst non-profi t association for clinical trial professionals. One of its aims is to support the domestic adaptation of international recommendations, and in particular Good Clinical Practice (GCP). The Society has been active in developing the Ministerial Decree 35/2005 on Clinical Trials. Another aim of the Society is to ensure continuous education for minimally qualified people who are involved in organising clinical trials in order to perform trials at a high professional level in Hungary. Numerous members of the Society are active in the International GCP Course, which is organised yearly by WHO-Szeged University and CTMS – MKVT.

REGULATORY ENVIRONMENT

Clinical studies in Hungary are governed by the Decree 35/2005 (VIII 26) of the Minister of Health on the clinical trial and application of correct clinical practices of investigational medicinal products intended for use in humans. The approving health authority is the GYEMSZI and the approval process takes 60 days. This process is easy to use and transparent, with is one central committee. The Medical Research Council, the ethics committee for clinical pharmacology, is responsible for the ethical approval of all drug related clinical trials.

OVERALL COSTS

The opportunity to offer more rapid subject enrolment and gain access to experienced clinical research professionals, thus achieving higher compliance, high subject retention and the positive regulatory environment, results in more attractive costs of clinical trials. Figure 5 offers an evaluation of the costs of clinical research – still considerably cheaper in Hungary.

CONCLUSION

Hungary has always been an attractive place for clinical research due to its patients, motivated and qualifi ed investigators and positive regulatory environment in general. Over the last two decades, the experience of clinical research professionals has increased, while the regulatory environment and the infrastructure for clinical research has improved. Patients are not only available in high numbers and at concentrated areas, but they too have become more knowledgeable about clinical research. The future of Hungary as a solid and reliable arena for conducting clinical trials looks positive.

References

  1. http://www.centerwatch.com/
  2. www.kormany.hu/download/3/c4/40000/Semmelweis%20Terv%20 szakmai%20koncepci%C3%B3%202011.%20j%C3%BAnius%2027.pdf
  3. The list of the accredited Phase I Units accredited by GYEMSZI can be found at: http://www.ogyi.hu/dynamic/fazis_i_2011_04.xls
  4. http://www.eum.hu/miniszterium/intezmenyek/orszagos-gyogyito
  5. 5. Ex accredited hepatology center for the treatment of viral hepatitis, http://www.hepatologia.hu/index.html

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Suzanne Pozsonyi has more then 20 years of experience in clinical research. She was instrumental in setting up the fi rst international CRO in CEE in the early 1990s. She worked in various roles at major CROs before founding her own consulting company, SynCon International, in 2005, with the aim of supporting companies who want to do business in the emerging regions of Central and Eastern Europe and Latin America. Suzanne is active in several professional organisations, lecturing on emerging regions or support with patient organisations. She is also leading the work of the international relations working group of the Clinical Trial Management Society of Hungary. Email: s.pozsonyi@syncon.hu
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