British Journal of Research Open Access

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Abstract

Direct Impact and Cost-effectiveness of Clinical Research in the Clinical Outcome of Metastatic Renal Cell Carcinoma (mRCC) and G1 and G2 Neuroendocrine Tumors (NETs): a Real-Life Analysis in a Large Public University Hospital in Spain

García-Garro

Clinical research leverages cancer patient care outcomes. We analyzed the direct impact of clinical research in terms of clinical outcomes and costs related expenses in patients with mRCC and G1-G2 NETs (mNET) in the reallife setting. We retrospectively collected data from all mRCC and mNET patients who were treated with oral tyrosine-kinase and mTOR inhibitors and/or SST analogues at the Medical Oncology Department of Ramón y Cajal University Hospital between Jan 2010 and Feb 2017. Statistical analysis comparing the outcomes and health-related costs of patients included in clinical trials vs. those who were not recruited was conducted. A total of 104 patients were included in the data analysis. Trial patients showed a higher median OS (70 vs. 29 months. HR 0.502; 95% CI: 0.293-0.860; p=0.010). There was a positive relationship between the permanence in trials and the improvement of OS in the enrolled trial patients (Percentage of time in treatment under a trial: 60.67% survivors vs. 41.40% deaths). The average expenses of the non-participant patient´ care were €60,888 while trials reduced health costs in €30,137. Trial participants had fewer hospitalizations (0.92 vs.1.91) and emergency visits (0.78 vs. 3.81). Taking data together, under the public health system perspective, participation clinical trials correlates to an improvement in OS in mRCC and NET patients and contributes to a reduced health- costs in both entities. Silvia García-Garro has a Pharmacist Degree from Alcalá University and she is doing her PhD Studies in Clinical Medicine from Alcalá University, Madrid. She has two MSc degrees in Therapeutic Targets of Cell Signaling (Research and Development) and in Clinical Trials. Furthermore, she has a Diploma University Degree in Medical Genetics at The University of Valencia. She started her career researching/collaborating with the Cancer Research UK and the Spanish National Centre for Oncological Research (CNIO). Nowadays, she is working as a Clinical Study Coordinator/Clinical Trial Manager at MD Anderson Cancer Center in Madrid. She is a Membership at the Cancer Epigenetics Society.