OBJECTIVES : Clinical trials represent an important R&D activity for university clinical centers and teaching hospitals, generating significant revenues for the health care providers from the industry. However, few information is available on health insurance cost related to clinical trials. The aim of our study was to calculate the annual official additional health insurance cost related to the treatment and complications of patients involved into clinical trials.

METHODS : The health insurance out- and inpatient care expenditure data derive from the financial database of the Hungarian National Health Insurance Fund Administration (NHIFA), the only health care financing agency in Hungary. Data on industrial trials derived from National Institute of Pharmacy and Nutrition (OGYÉI), who is responsible for market authorization for drugs in Hungary.

RESULTS : In 2014 altogether 336 clinical trial was approved by the OGYÉI in Hungary, invoving 19899 patient and generating 30.83 billion Hungarian Forint (HUF) (132.5 million USD) for the hospitals. In 2015, this market included 349 trials, 17415 involved patients and 34.5 billion HUF (123.5 million USD) revenues. In 2014 the health insurance out- and inpatient care expenditures related to clinical trials was 16.38 million HUF (70878 USD), while in 2015 it was 13.57 million HUF (48552 USD). The volume of health insurance expenditures related to clinical trials as a proportion of revenues coming from industry was 0.06 % in 2015 and 0.04 % in 2015.

CONCLUSIONS : The proportion of health insurance expenditures related to clinical trials as a percent of revenues coming from industry was unexpectedly low in Hungary.