OBJECTIVES: In clinical trials, the greatest challenge is often patient recruitment. Finnish biobanks (FINBB) have developed a national patient recall service in Fingenious^® (PRS) that aims to enhance patient recruitment and benefit various stakeholders. We assessed the value generated by the PRS.

METHODS: The PRS was compared to a conventional patient recruitment method with a value assessment model (VAM) developed using the R programming language. The PICOSTEPS (patients-intervention-comparator-outcomes-setting-time-effects-perspective-sensitivity analysis) health technology assessment framework was applied in the VAM dash and published inputs were used.

To assess the value generated by the PRS, a therapy life cycle from the start of a clinical trial to patent expiry was modelled with (intervention) and without (comparator) the PRS. Outcomes were total value in euros and quality-adjusted life years (QALYs) based on the value of earlier trial initiation with a 3% annual discount rate. The maximum time horizon of the model was limited to the time of the drug patent expiry.

The modelled effects were based on an earlier market entry and on the expectation that an additional research site would be established in Finland due to PRS. Finnish society, global pharmaceutical, and patient perspectives were applied in the VAM. Inputs were changed ±10% of applied value to assess the robustness of the results.

RESULTS: The total expected per trial value generated by PRS was 46,883,192€, or alternatively 545.74 QALYs at a willingness-to-pay of 70,000€/QALY gained. For the comparator, the expected value was -371,772€ or alternatively -5.31 QALYs. Thus, the value added by PRS amounts to 47,254,964€ or alternatively 551.05 QALYs.

CONCLUSIONS: The additional value of PRS for clinical trials in the Finnish setting was predicted with a VAM, based on benefits accruing to patients, pharmaceutical companies, and society. The VAM will be tested and calibrated with real world data accrued during PRS trials.