Article Text
Abstract
Background and Importance Clinical trials are the main source of information to establish new treatments’ efficacy and safety. Patients’ enrolment in these studies may result in economic benefits for the participating sites since usually the costs derived from their inclusion are funded by sponsors. However, these economic benefits are rarely quantified.
Aim and Objectives The primary object of this study was to calculate the economic benefit obtained from patients’ inclusion in lung cancer clinical trials in two scopes: medication and medical tests. The secondary object was to determine whether avoided costs in medication were significantly different from those in medical tests.
Material and Methods An observational retrospective study was conducted in all patients enrolled in lung cancer clinical trials from 2017 to 2021 at our hospital.
The avoided costs in medication were calculated considering the medication which would have been given to the patient in the standard of care taking into account their specific data.
The avoided costs in medical tests per patient were calculated from the prices published and the total number of each test performed on each patient from their first treatment visit until the end of the treatment visit.
The homogeneity of the two groups was analysed using a univariate analysis by applying the chi-square test for qualitative variables and the t test or Mann-Whitney test to compare quantitative variables. A p value of <0.05 was considered statistically significant.
Results The economic benefit generated from sponsor-provided drugs in the 35 clinical trials was 3,778,393.93€.
A total of 642 medical tests were performed in the 117 patients under study. Specifically, 546 were CTs, 58 were MRs, 6 PETs and 32 were gamma graphics. The total economic benefit generated in five years by the sponsor financing these tests was 128,448€.
The results from the statistical analysis revealed that the economic differences between sponsors providing the medication and financing the medical tests were significantly different with p<0.05 (p=0.0482).
Conclusion and Relevance In the 5 years studied, over 3.9 million euros were saved by including patients in lung cancer trials in one site, being 96.7% derived from avoided costs in medication. Thus, the participation of patients in clinical trials is economically beneficial for them and society.
Conflict of Interest No conflict of interest.