Medidata Solutions Database Tools to be Used in National Bureau of Economic Research Study that Examines Clinical Trial Costs

Medidata Solutions announced that a National Bureau of Economic Research (NBER) research project will use industry benchmark cost data from Medidata Grants Manager and Medidata CRO Contractor to investigate the major causes of increasing drug development costs. The study, 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, examines the feasibility of constructing price indexes for clinical trials.

The rising cost of drug development in recent years has been attributed to a number of forces, such as new patient populations and increasing trial complexity, but the relative weight of the various cost components has been difficult to determine due to a lack of accurate data. The NBER researchers will use the data from Medidata’s proprietary clinical trial cost databases PICAS and CROCAS, accessed through Medidata Grants Manager and Medidata CRO Contractor, to build and test the feasibility and accuracy of cost indices to track clinical development costs.

Medidata’s databases contain 15 million data points from clinical trials, derived from more than 250,000 investigative site grants, 8,000 contracts with contract research organizations and more than 27,000 study protocols. The data is derived from real-world, negotiated grants and is associated with factors such as geography, types of studies and therapeutic areas. Medidata’s database tools are designed to assist clinical trial researchers develop accurate trial budgets, ensure fair and consistent investigator payments, mitigate compliance risks, and accelerate site enrollment. Grants Manager and CRO Contractor are used globally by pharmaceutical, biotechnology, and medical device companies as well as contract research organizations and others responsible for budgeting and managing clinical trials.

As the reduction of healthcare expenditures continues to be a focus of national economic reform, the results of the study, which Berndt and Cockburn anticipate releasing in the spring of 2011, are expected to influence government and commercial pharmaceutical and biotech research by pinpointing components that rise faster or slower than trial costs as a whole.