Hungary
Hungary, in general, boasts a very innovative and well-organized infrastructure for clinical trials. The country’s involvement in clinical trials is outstanding within Europe: placing 10th in terms of the number of trials and 4th in terms of accessibility and availability of trials per capita. Due to the Hungarian (unique) centralized healthcare system, companies looking to conduct clinical trials here can find the right number of patients with good quality sites and supportive authorities
Hungary is a strategic destination for many big Pharma company’s clinical activity within Europe.
As Hungary is a member of the European Union all the regulatory processes are harmonized. There is only 1 stop sytem with regulatory submission of initial study documents. The Regulatory Authority (OGYÉI) communicate with the Central Ethics Committee (CEC) internally and the final approval is given by the Authority including the CEC opinion. The local ethics committees do not get any rights on study approvals.
The percentages of inspections after which no follow-up action was indicated were 36.9% for Western Europe, 55.7% for CEE, and 44.3% for US sites. CEE was also the region with the lowest percentage of inspections that required official or voluntary action. On the basis of FDA inspection data, the high productivity of CEE sites appears to be accompanied by regulatory compliance as well as by data quality standards that are not inferior to those in Western regions.” Based on the FDA’s publicly accessible Clinical Investigator Inspection List.
The country population is about 10 million. All hospitals are owned by the Government. There are only a few outpatient privet clinics and a few of them provide inpatient services. All Hungarian citizens health data is stored in the National Insurance database. This uniqe database contains all medical information of all Hungarian citizens. Governmental hospitals are well equiped (except a few ones at very rural areas) with well trained and clinical research experienced medical staff.
CRU-GLOBAL local affiliate is: CRU Hungary Ltd., the first CRU unit, established in 2007.
CRU Hungary gets an Early Phase Unit with 12 beds in Miskolc, which is the biggest accredited Phase I Unit in Hungary since 2015. The site is located within the 2nd biggest hospital of Hungary (BAZ County Central Hospital and University Teaching Hospital). CRU also gets a Later Phase Unit within this city. The permanent staff at these 2 sites is 37 employees and an additional 14 as external consultants. The number of studies is over 50/year. The catchment area of this site is about 1,2 million inhabitants.
CRU Hungary gets an additional site in Kisvarda within the Felso-Szabolcsi Hospital for outpatient studies with a catchment area of 0,6 million inhabitants and in Hatvan city with a catchment area of 0.4 million inhabitants.