This study evaluated the effect of pharma sponsored and investigator initiated clinical trials on hospitals’ pharmaceutical expenditure. In a four-week period 126 patients treated in clinical trials were analyzed in order to quantify drugs cost reduction related to the participation in clinical trials at National Cancer Institute of Naples. Our analysis demonstrated that the hospital has saved about 517,658 Euros in a month for drugs that, otherwise, would have been loaded on the Italian National Healthcare Service. If calculated with the same number of patients and in a one-year period, this saving could potentially translate into a significant drug cost reduction that exceed 6 million Euros, representing roughly 20% of the total spending for cancer drugs. To date, very few studies have evaluated the potential economic impact of patient participation in clinical trials in terms of drug cost savings, in particular with new immunotherapeutic and target based agents. This is a very important issue for health organizations, considering that the cost of anticancer drugs is constantly growing. Our study showed that participating in clinical trials with investigational anticancer drugs provided free of charge by the Sponsor translates into considerable cost savings, and tangible benefits in both clinical and administrative strategies for reducing drug expenditures. These findings should encourage the participation in clinical trials of an increasing number of Oncology Units (even outside Cancer Centers and Academic Institutions) overcoming the concern about the expected increased costs sustained by health organizations for conduction of clinical trials. McDonagh et al. [
5] examined the costs and savings resulting from two pharmacy-based investigational drug services for fiscal years 1996–97. They showed that there was a cost avoidance of 2.9 Million Dollars in drug costs, which was equivalent to 8% of the institutions’ annual drug budget for 1996–1997. LaFluer et al. [
6], through a review of the study protocols and dispensing data for the investigational drug studies over 2 years, have demonstrated that clinical trials participation achieves considerable drug cost avoidance, according to the type of study and the disease category involved. Uecke et al. [
7] quantified drug cost savings in hospitals related to clinical trials and analyzed 88 clinical trials in oncology including 29 researchers in 11 hospitals in Germany from 2002 through 2005 with the aim to examine the relationship between researchers and hospital administrators with respect to clinical trials. The results showed a drug cost savings potential of 5.1 million Euros and an actual cost savings of 1.5 million Euros. In a retrospective cost attribution analysis to quantitate the treatment costs associated with cancer clinical trial protocols conducted in a single UK institution during 2009 and 2010 period, Liniker et al. [
8] determined an overall treatment cost savings of 388,719 Pounds in 2009 and 496,556 Pounds in 2010, largely attributable to pharmaceutical company provision of free drug supplies. Grossi et al. [
9], evaluated the cost of drugs administered in clinical practice and in clinical trials for a single Italian Lung Cancer Unit and they demonstrated that participation in clinical trials offers substantial cost savings for the Italian NHS related to drug provided free of charge by sponsors. They quantified these savings in 243,154 Euros (about 30% of the overall cost of those antineoplastic drugs charged to hospital during 2010). Calvin-Lamas et al. [
10], carried out an observational of prevalence study with retrospective collected data related to prostate cancer clinical trials during the study period (1996–2013), demonstrating a total cost avoidance of 696,002 Euros and an average cost avoidance per patient was 5118 Euros. Finally, Manes-Sevilla et al. [
11], in a retrospective observational study of the drug cost avoidance during the study period (2014–2016), calculated a total cost avoidance of 957,246 Euros and an average cost avoidance per patient of 10,756 Euros related to the free drugs supplied by the sponsors. They included thirty-seven clinical trials, with a total of 89 breast cancer patients, in this study. Our study confirmed these findings showing a significant cost savings related to investigational drugs that are provided to the hospital free of charge by the sponsor also in the era of immunotherapy. Other strengths of our study are the inclusion of patients with different cancers, in different settings of therapy (adjuvant and metastatic disease), treated within pharma sponsored and investigator initiated phase I, II and III clinical studies: all this allows for greater generalizability of data.
However, conducting clinical trials determines additional costs that inevitably loads on the hospital, which could affect the real economic benefit of drug cost saving. This represents a limit of the analyses conducted in our study, because we calculated the drug cost savings without taking into account the costs involved in the conduction of clinical trials. In our previous research [
12], we estimated that for patients included in clinical trials, the average “per patient” total costs accounted for 11.379 Euros, including overhead costs of clinical trials. Nonetheless, it should also be considered that sponsored clinical studies are repaid entirely through sponsors’ grant (generally related to performing the activities envisaged by the protocol). Another weakness of our study could be the limited period of time chosen for the analysis. However, a 4 week period was empirically considered long enough for the purpose of the study, due to the high number of patients treated within clinical trials at our Cancer Center.