ABSTRACT
The objective of this single-center retrospective study was to describe the clinical characteristics of adult patients with solid tumors enrolled in cancer clinical trials over a 10-year period (2010-2019) and to assess drug cost avoidance (DCA) associated with sponsors' contributions. The sponsors' contribution to pharmaceutical expenditure was calculated according to the actual price (for each year) of pharmaceutical specialties that the Vall d'Hebron University Hospital (HUVH) would have had to bear in the absence of sponsorship. A total of 2930 clinical trials were conducted with 10,488 participants. There were 140 trials in 2010 and 459 in 2019 (228% increase). Clinical trials of high complexity phase I and basket trials accounted for 34.3% of all trials. There has been a large variation in the pattern of clinical research over the study period, whereas, in 2010, targeted therapy accounted for 79.4% of expenditure and cytotoxic drugs for 20.6%; in 2019, immunotherapy accounted for 68.4%, targeted therapy for 24.4%, and cytotoxic drugs for only 7.1%. A total of four hundred twenty-one different antineoplastic agents were used, the variability of which increased from forty-seven agents in 2010, with only seven of them accounting for 92.8% of the overall pharmaceutical expenditure) to three hundred seventeen different antineoplastic agents in 2019, with thirty-three of them accounting for 90.6% of the overall expenditure. The overall expenditure on antineoplastic drugs in clinical care patients not included in clinical trials was EUR 120,396,096. The total cost of antineoplastic drugs supplied by sponsors in a clinical trial setting was EUR 107,306,084, with a potential DCA of EUR 92,662,609. Overall, clinical trials provide not only the best context for the progress of clinical research and healthcare but also create opportunities for reducing cancer care costs.
ABSTRACT
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Subject(s)
Renal Insufficiency/drug therapy , Creatinine/administration & dosage , Drug Dosage Calculations , Creatinine/standardsABSTRACT
AIMS: Accurately estimating kidney function is essential for the safe administration of renally cleared drugs such as ganciclovir. Current practice recommends adjusting renally eliminated drugs according to the Cockcroft-Gault equation. There are no data on the utility of the Modification of Diet in Renal Disease (MDRD) and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations in ganciclovir dosing. To evaluate which renal function equation best predicts ganciclovir clearance. METHODS: The performance of the Cockcroft-Gault equation, isotope dilution mass spectrometry (IDMS)-traceable 4-variable MDRD study (MDRD4-IDMS) equation and CKD-EPI equation in determining ganciclovir clearance were assessed retrospectively in patients treated with ganciclovir from 2004-2015. The MDRD4-IDMS and CKD-EPI equations adjusted to individual body surface area (MDRD4-IDMS·BSA and CKD-EPI·BSA, respectively) were also evaluated. Patients with intravenous ganciclovir peak and trough concentrations in their medical records were included in the study. Ganciclovir clearance was calculated from serum concentrations using a one-compartment model. The five equations were compared based on their predictive ability, the coefficient of determination, through a linear regression analysis. The results were validated in a group of patients. RESULTS: One hundred patients were included in the final analysis. Seventy-four patients were analysed in the learning group and 26 in the validation group. The coefficient of determination was 0.281 for Cockcroft-Gault, 0.301 for CKD-EPI·BSA, 0.308 for MDRD4-IDMS·BSA, 0.324 for MDRD4-IDMS and 0.360 for CKD-EPI. Subgroup analysis also showed that CKD-EPI is a better predictor of ganciclovir clearance. Analysis of the validation group confirmed these results. CONCLUSIONS: The CKD-EPI equation correlates better with ganciclovir clearance than the Cockcroft-Gault and MDRD4-IDMS equations, even the clinical difference between the equations is scarce.
