Year: 2025
Type: conference-paper
Study design: Observational Study
Abstract: Background and Importance It is necessary know the profitability of clinical trials (CT) due to sponsors provided drugs free of charge, particularly in pathologies which have a high economic impact on hospital budget. Aim and Objectives To quantify the avoided cost (AC) of coagulation factors derived from participation on congenital coagulopathies (CC) CT. Material and Methods Retrospective, observational study of CT conducted in CC at a tertiary hospital during 2022–2023. Inclusion criteria: active CT during the study period in CC. Exclusion criteria: CT without included patients. Data sources: CT management software, pharmacy service management database, and electronic medical records. Recorded data: protocol code, sponsor, pathology, patients included/CT, prior treatment (medicinal product and posology) before enrollement in the CT, cost of that treatment (laboratory purchase price [LPP] + value added tax - applied discounts on LPP), and time elapsed from inclusion in the CT to the prescription of a new treatment. Variables: total AC during 2022–2023, average AC/CT, and average AC/patient. For the calculation of AC, considered medicinal product and posology that patients received before enrolment in CT and doses they would have received if not enrolled. Results 5 CT in CC were carried out between 2022–2023. 1/5 CT excluded for not recruiting patients. The 4 included CT were open and sponsored by the pharmaceutical industry. 2 CT studied haemophilia A and 2 CT haemophilia A or B. 5 patients were enrolled (range 1–2), all diagnosed with severe haemophilia A. Prior treatment to CT was standard half-life (SHL) factor VIII (FVIII) in 3 patients and extended half-life (EHL) FVIII in 2 patients. Total AC: 829,545€. AC in SHL FVIII: 491,650€, and in EHL FVIII: 337,896€. The total expenditure on FVIII in our hospital between 2022–2023 was 2,065,202€ for SHL FVIII and 4,771,999€ for EHL FVIII, so the 4 included CT represented 23.8% and 7.1% economic savings for hospital, respectively, on the total expense. Average AC/CT: 207,386€ (range: 77,064€-453,980€). Average AC/patient: 165,909€ (range: 77,064€–260,832€). Conclusion and Relevance Avoided cost of medications associated with participation in CT contributes to the sustainability of the healthcare system. Also, CT increase scientific knowledge and allow early access for patients to innovative treatments. References and/or Acknowledgements Conflict of Interest No conflict of interest
Institution: Complexo Hospitalario Universitario A Coruña
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4408376122