Based on data on the clinical trial activity across Central and Eastern Europe – as stated also in the chart below – Hungary is one of the most popular countries for running trials in the region. Hungary has the highest number of ongoing registered clinical trials in 2016 in the region.
Ongoing Studies in Central and Eastern European Countries
EU Clinical Trial Register
(date of data collection: 29/APR/2016)
| Country | Number of Studies | Population (millions) |
| Hungary | 2 325 | 9.9 |
| Austria | 2 273 | 8.7 |
| Bulgaria | 848 | 7.7 |
| Croatia | 135 | 4.4 |
| Czech Republic | 2 190 | 10.6 |
| Estonia | 562 | 1.3 |
| Latvia | 545 | 2.0 |
| Lithuania | 643 | 2.9 |
| Poland | 1 189 | 38. |
| Romania | 162 | 21.7 |
| Slovakia | 547 | 5.4 |
| Slovenia | 209 | 2.0 |
source:
https://www.clinicaltrialsregister.eu/ctr-search/search
https://www.cia.gov/library/publications/the-world-factbook/
The outstanding number of clinical studies in Hungary is the result of the country’s good reputation in clinical research that is based on the recognized excellence in project delivery and quality. This means that Hungary shows solid performance across all therapeutic areas, has consistent start-up timelines and excellent quality.
The results of FDA inspections also reflect the good performance of the investigators. The proportion of inspections with the conclusion that „No Action was Indicated” is remarkably higher in Hungary than in the US and in many other countries in Europe. There has been no inspection at all in our country with the conclusion of „Official Action Indicated”.
FDA Inspections by Indicated Action in Selected Countries in Europe
| Country | OAI % | NAI % | VAI % | No of Ispections |
| Hungary | — | 55.3% | 44.7% | 38 |
| Great Britain | 4.0% | 32.5% | 61.1% | 126 |
| Germany | 2.4% | 42.9% | 51.6% | 126 |
| Czech Republic | — | 52.9% | 47.1% | 34 |
| Austria | — | 29.4% | 64.7% | 17 |
| Lithuania | — | 25.0% | 75.0% | 4 |
source:
http://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm (02/MAY/2016)
Abbreviations:
NAI, no action indicated; VAI, voluntary action indicated; OAI, official action indicated.
FDA Inspections by Indicated Action
| Western Europe | Central and Eastern | USA | Other | Total | |
| NAI | 36.9% | 55.7% | 44.3% | 43.6% | 44.2% |
| VAI | 58.6% | 43.5% | 53.4% | 54.8% | 53.5% |
| OAI | 4.5% | 0.9% | 2.2% | 1.6% | 2.3% |
| n | 401 | 230 | 3858 | 376 | 4865 |
source:
Caldron et al, Drug Des Devel Ther. 2012; 6: 53–60.
abbreviations:
NAI, no action indicated; VAI, voluntary action indicated; OAI, official action indicated.
Hungary has an excellent reputation also for its regulatory authority and central ethics committee evaluation process. We have one integrated submission process to the two evaluator bodies and the process goes in a parallel way resulting – in the majority of cases – that the approval is available within 60 days. This process usually enables us to outperform any other participating countries in trial start time and this is why it is typical that in multinational trials the first patients are enrolled in Hungary.
As Baláti CRO operates in Hungary with over 15 years of therapeutic, operational and regulatory experience and expertise and has strong relationship with sites that have demonstrated excellent enrollment results, we are an ideal partner for conducting trials in Hungary.