Avoided Costs and Economic Benefits Associated with Sponsored Clinical Trials

Abstract

The benefits associated with randomized clinical trials (RCTs) for patients, investigators, and sponsors are well known. However, little has been done to estimate the economic benefits related to spon- soring a RCT. Herein, a methodological analysis is proposed to assess the economic benefits and cost-savings of a RCT, namely the trial avoided costs (TAC). The TAC was considered to be cost-saving for the investigational medicinal product (IMP) (i.e., the drug adverted cost) and the diagnostic tests (i.e., procedure adverted cost) in a RCT. This tool is potentially helpful in understanding the financial impact of RCTS on healthcare institutions and provides the opportunity to invest budgets in other resources (i.e., core facilities, research infrastructure, human resources) that can increase the quality of clinical research.