OBJECTIVES: Medicines require clinical research evidence and health technology assessments (HTA) for marketing authorisation, labelling, market access, and lifecycle management. However, clinical drug research itself is rarely subjected to HTA.

We evaluated how Finland may benefit from industry-sponsored clinical drug trials compared to counterfactual situation, where industry-sponsored trials are not performed.

METHODS: HTA was carried out within the PICOSTEPS analysis and reporting framework, based on data requested from 30 organizations (5 university hospitals, 16 central hospitals, 5 hospitals under Finnish Institute for Health and Welfare, and 4 wellbeing service counties without central hospital), annual surveys by Pharma Industry Finland, and public statistics and reports using Finnish public health care perspective. Assessment included industry-sponsored clinical drug trials but excluded vaccine trials.

RESULTS: 20 organizations (67 %) responded to the data request; 10 were carrying out clinical trials at the time of data request. The average direct value of care provided in one clinical trial was estimated at 1.2 million euros including drugs paid by study sponsors (41 %), treatment and monitoring covered by the contract payments (34 %), and health benefits for the study subjects (25 %).

The average value of one clinical trial for Finnish society was around 10 million euros including spill-over effects (health benefits elsewhere in health care 73 % and cost benefits elsewhere in health care 15 %), drugs paid by study sponsors (5 %), treatment and monitoring covered by the contract payments (4 %), and health benefits for the study subjects (3 %). During years 2018-23, the direct value of care provided in the initiated clinical trials was around 107 million euros and the societal value around 880 million euros annually.

CONCLUSIONS: Clinical trials create considerable societal value, of which 12 % is direct value. Results highlight the need to consider the indirect benefits of research.