chapter  3
10 Pages

Sponsor, Site, and Study Start-Up

The cost of developing and bringing a new drug to market is extremely high. In a 2014 study by the Center for the Study of Drug Development at Tufts University, the cost of bringing a single drug to market was estimated at US $2.558 billion (DiMasi, Grabowski, & Hansen, 2016, p. 25). Of that amount, approximately US $1.460 billion was attributed to the cost of conducting clinical trials (DiMasi et al., 2016, p. 25). With this amount of money at stake, sponsors are motivated to collaborate with research sites that are prepared and ready to initiate a clinical trial in a timely manner once the clinical trial protocol and related documents are approved by the institutional review board (IRB).