Current issue
Journal content
Articles in press
Archive
About the Journal
About the Polish Annals of Medicine
Editorial Board
Abstracting & indexing
Open Access policy
Charges
Affiliated institutions
Contact
Instructions
Peer review process
Guide for authors
Publication ethics
Ethics and Patient Consent
User License
Usage of third party materials
Disclaimer
Statement on Artificial Intelligence
Reviewers
Guide for reviewers
Review Form
RESEARCH PAPER
Number of clinical trials of new therapeutic agents in the European Union countries of Central and Eastern Europe, 2000–2019
1
Department of Immunobiology, Poznan University of Medical Sciences, Poland
2
Department of Chemotherapy, The Greater Poland Cancer Center, Poznan, Poland
3
Department of Electroradiology, Poznan University of Medical Sciences, Poland
4
Department of Cancer Pathology and Prevention, Poznan University of Medical Sciences, Poland
Submission date: 2021-01-05
Final revision date: 2021-03-04
Acceptance date: 2021-03-04
Online publication date: 2021-03-17
Corresponding author
Mikołaj Bartoszkiewicz
Department of Chemotherapy, The Greater Poland Cancer Center, ul. Garbary 15, 61-866 Poznań, Poland. Tel.: +48 61 885 04 80.
Department of Chemotherapy, The Greater Poland Cancer Center, ul. Garbary 15, 61-866 Poznań, Poland. Tel.: +48 61 885 04 80.
Pol. Ann. Med. 2022;29(1):26-30
KEYWORDS
TOPICS
ABSTRACT
Introduction:
The clinical research market of the European Union (EU) countries of Central and Eastern Europe has been experiencing a dynamic growth of clinical trials in the last 10 years. Oncology and cardiology are the areas where the most clinical trials are conducted.
Aim:
This study aims to analyze the clinical research market including countries, medical fields and trial phases in the EU countries of Central and Eastern Europe. The comparative analysis of countries is divided into 5-year periods.
Material and methods:
Clinical research market analysis was carried out in 11 EU countries of Central and Eastern Europe: Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia. In searching for the number of clinical trials, the ClinicalTrials.gov database was used.
Results and discussion:
From 2000 to 2019, 6497 clinical trials were conducted in the EU countries of Central and Eastern Europe. There were 1840 clinical trials registered in Poland, 1188 in Czechia, and 1005 in Hungary. The most clinical trials were registered in the field of oncology (22%), followed by cardiology (16%) and neurology (12%). Phase III trials representing as much as 60% (n = 2854) of all conducted medical experiments. The highest increase in the number of clinical trials in the last two 5-year periods (2010–2014 and 2015–2019) was recorded in Estonia, at 471%.
Conclusions:
There has been a significant increase in the number of clinical phase III trials in the EU countries of Central and Eastern Europe, mainly in Poland, Czechia, and Hungary.
The clinical research market of the European Union (EU) countries of Central and Eastern Europe has been experiencing a dynamic growth of clinical trials in the last 10 years. Oncology and cardiology are the areas where the most clinical trials are conducted.
Aim:
This study aims to analyze the clinical research market including countries, medical fields and trial phases in the EU countries of Central and Eastern Europe. The comparative analysis of countries is divided into 5-year periods.
Material and methods:
Clinical research market analysis was carried out in 11 EU countries of Central and Eastern Europe: Bulgaria, Croatia, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia. In searching for the number of clinical trials, the ClinicalTrials.gov database was used.
Results and discussion:
From 2000 to 2019, 6497 clinical trials were conducted in the EU countries of Central and Eastern Europe. There were 1840 clinical trials registered in Poland, 1188 in Czechia, and 1005 in Hungary. The most clinical trials were registered in the field of oncology (22%), followed by cardiology (16%) and neurology (12%). Phase III trials representing as much as 60% (n = 2854) of all conducted medical experiments. The highest increase in the number of clinical trials in the last two 5-year periods (2010–2014 and 2015–2019) was recorded in Estonia, at 471%.
Conclusions:
There has been a significant increase in the number of clinical phase III trials in the EU countries of Central and Eastern Europe, mainly in Poland, Czechia, and Hungary.
FUNDING
None declared.
CONFLICT OF INTEREST
None declared.
REFERENCES (17)
1.
European Hearth Network. European Cardiovascular Disease Statistics 2017. Brussels: EHN AISBL. http://www.ehnheart.org/cvd-st.... Accessed: 03.06.2020.
2.
World Health Organization. Cancer Data and Statistics. http://www.euro.who.int/en/hea.... Accessed: 03.06.2020.
3.
Gehring M, Taylor RS, Mellody M, et al. Factors influencing clinical trial site selection in Europe: the Survey of Attitudes towards Trial sites in Europe (the SAT-EU Study). BMJ Open. 2013;3(11):e002957. https://doi.org/10.1136/bmjope....
4.
Hearn J, Sullivan R. The impact of the ‘Clinical Trials’ directive on the cost and conduct of non-commercial cancer trials in the UK. Eur J Can. 2007;43(1):8–13. https://doi.org/10.1016/j.ejca....
5.
Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products. OJ L 91, 9.4.2005. https://eur-lex.europa.eu/lega....
6.
Ancans J. Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development. Front Immunol. 2012;3:253. https://dx.doi.org/10.3389%2Ff....
7.
Tenti E, Simonetti G, Bochicchio, MT, Martinelli G. Main changes in European Clinical Trials Regulation (No 536/2014), Contemp Clin Trials Commun. 2018;11:99–101. https://dx.doi.org/10.1016%2Fj....
8.
Regulation (EU) No 536/2014 of the European Parliament and of the council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC.OJ L 158, 27.5.2014, 1–76. https://eur-lex.europa.eu/lega....
9.
Grielen SJ, Boerma WG, Groenewegen PP. Science in practice: Can health care reform projects in central and eastern Europe be evaluated systematically? Health Policy. 2000;53(2):73–89. https://doi.org/10.1016/s0168-....
10.
Rechel B, McKee M. Health systems and policies in South-Eastern Europe. In: WHO, ed. Health and Economic Development in South-Eastern Europe. Paris: WHO; 2006:43–69.
11.
Healy J, McKee M. Implementing hospital reform in central and eastern Europe. Health Policy. 2002;61(1):1–19. https://doi.org/10.1016/s0168-....
12.
Dubois CA, McKee M. Health and health care in the candidate countries to the European Union: common challenges, different circumstances, diverse policies. In: McKee M, MacLehose L, Nolte E, eds. Health Policy and European Union Enlargement. Maidenhead: Open University Press, 2004:43–63.
13.
Eldar R. Activities for quality of care improvement in the countries of central eastern Europe. Croatian Med J. 2001;42:692–95.
14.
Tit A, Marjan C, Don H, et al. Health Care Systems in Transition: Slovenia. World Health Organization. Regional Office for Europe; 2002. https://apps.who.int/iris/hand.... Accessed: 20.12.2020.
15.
Rechel B, McKnee M. Health reform in central and eastern Europe and the former Soviet Union. Lancet. 2009;374(9696):1186–1195. https://doi.org/10.1016/S0140-....
16.
Nass SJ, Balogh E, Mendelsohn J. A National Cancer Clinical Trials Network: recommendations from the Institute of Medicine. Am J Ther. 2011;18(5):382–391. https://dx.doi.org/10.1097%2FM....
17.
Puchała Ł, Maksymowicz S, Siwek T, Mycko MP. Edaravone, a new therapeutic option in amyotrophic lateral sclerosis: evaluation of challenges in the drug accessibility. Pol Ann Med. 2020;27(2):220–224. https://doi.org/10.29089/2020.....
We process personal data collected when visiting the website. The function of obtaining information about users and their behavior is carried out by voluntarily entered information in forms and saving cookies in end devices. Data, including cookies, are used to provide services, improve the user experience and to analyze the traffic in accordance with the Privacy policy. Data are also collected and processed by Google Analytics tool (more).
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
You can change cookies settings in your browser. Restricted use of cookies in the browser configuration may affect some functionalities of the website.
