Evaluación del impacto económico de los Ensayos Clínicos con medicamentos en un hospital universitario de segundo nivel

Abstract

The present study aims to estimate the cost of conducting clinical trials in a university hospital in both avoided cost of medication and patient management processes. Moreover, specifically, to estimate the cost of the hospital pharmacy’s participation in clinical trials and compare it to the amount received in compensation from sponsors. A retrospective observational study analysing data from five years (2014-2018) was carried out to estimate the economic impact of the trials in the hospital and the pharmacy service. We established two cost estimation protocols for both groups. We calculated the cost to the departments and the compensation received both overall and based on the type of sponsor, the clinical department involved in the trial and the number of patients included. The protocol applied to the hospital calculated the procedures of patients included in a clinical trial (medication and care processes). It was differentiated the cost of a standard patient from the patient included in the protocol, and it was compared with the costs assumed by the sponsor. The protocol applied to the pharmacy service was based on the allocation of direct costs related to the area’s activity (reception, maintenance, preparation, return or destruction of medication and monitoring visits) and indirect costs (facilities, resources of the area and support staff). A total of 62 trials, involving 318 patients, were included to estimate the impact on the hospital’s costs. Participation in these trials has generated real procedures’ costs for the centre of €620,271.87; of which €251,320.53 correspond to the excess generated by the extra procedures of the trials. The payments of the research promoters, with the exception of the non-commercial sponsor, have offset all the costs incurred. The clinical trials’ activity has generated a total income to the centre about €2,300,542.67 distributed in the different services involved in these activities. As for the costs related to study medication, the participation has meant a saving cost to the National Health System of €593,026.08; €517,791.64 corresponding to medication used and dispensed at the hospital, and €75,234.44 to medication dispensed at community pharmacies. A total of 134 trials were included to evaluate the impact on the pharmacy service. The costs for the service of the entire activity was €207,3772.95 and the amount invoiced to the sponsor was €149,128.93; which has made a negative difference of €58,244.02. Trials ending without recruiting patients (33.6%) and without compensation accounted for 57.45% of the deficit. The mean cost of trials ending without recruiting patients was €875. We plan to charge a reimbursable setup fee for opening clinical trials to safeguard against these losses. €875 for trials in all departments except oncology; €1,100 for oncology justified by the high percentage of both completed trials without patients (38%) and non-commercial sponsor that did not provide economic compensation (20%). A good cost-benefit ratio for public health in general terms and specifically in our hospital is derived from conducting trials. It has shown that participation in 62 trials has represented a benefit for our institution valued at €2,818,334.31, derived from the avoided cost of medication and the reimbursement system by the sponsor. Except for trials of a non-commercial sponsor, the payment per patient assumed by the sponsor not only assumes the cost of the extra procedures generated by the trial but also covers the cost of the standard procedures. However, in the pharmacy service billing sponsors based on costs incurred for each trial would be a fairer system than the current approach based on payment for included patients. Establishing an initial fee would make up for losses from trials that fail to recruit any patients.

Date of Award	21 Oct 2021
Original language	Spanish
Supervisor	Roser Vives Vilagut (Director) & Caridad Pontes Garcia (Tutor)