Medidata opens kimono for clinical trial cost study

Grabbing the bull by the horns, the National Bureau of Economic Research is investigating why drug development costs are rising. The bureau, a private nonprofit dedicated to promoting an understanding of how the economy works, wants to know if price indexes can be built for clinical trials.

Increases in drug development cost are likely caused by some combination of growing trial complexity, new patient populations and other factors. This research intends to go deeper, discerning the relative weight of the cost components.

The study is led by NBER research associates Iain Cockburn, a professor of finance and economics at Boston University School of Management, and Ernst Berndt, a professor in applied economics at MIT Sloan School of Management. An early item on their agenda was a visit with Medidata.

The researchers will tap industry benchmark cost data from the solution provider's Grants Manager and CRO Contractor products. They'll access the proprietary cost databases within the two solutions to build and test cost indices for clinical development. The data will help the researchers evaluate the variety of components that drive trial costs and watch their effects over time.

According to Medidata, the databases contain 15 million data points gleaned from 250,000 investigative site grants, 8,000 CRO contracts, and 27,000 study protocols. The data are derived from real-world, negotiated grants.

- here's the release