Department of Health and Human Services Launches Trial Research with Medidata Databases

By Allison Proffitt  

September 10, 2012 | The U.S. Department of Health and Human Services (HHS) has chosen Medidata’s trial cost benchmark data to support research into current cost data for clinical trials.   

The Assistant Secretary for Planning and Evaluation, the principal advisor to the Secretary of the U.S. Department of Health and Human Services on policy development, and consulting firm Eastern Research Group will analyze Medidata’s global databases of trial cost data to identify factors that delay or derail clinical studies and assess the economic benefit of implementing policies that encourage more streamlined clinical trials for the efficient delivery of safe and effective new therapies.  

Eastern Research Group and HHS are using Medidata Grants Manager and Medidata CRO Contractor, both tools for identifying prevailing rates for trial planning, budget development and grant negotiation. The results of the research are expected by the end of the year.    

Medidata Grants Manager’s database, PICAS, and CRO Contractor’s database, CROCAS, contain information from over 275,000 negotiated clinical site grants and almost 9,000 outsourced R&D contracts from 96 different countries and regions updated quarterly.   

The data are derived from actual negotiated contracts, analyzable at any combination of therapeutic level, phase or geography, in easy-to-use computer-based analytic tools.   

“Our data is representative of a global clinical environment because it’s purely negotiated cost,” explains Frank Cattie, Vice President, Trial Planning Solutions, for Medidata. These are not site’s list prices; they are final contract rates.    

“Medidata’s PICAS and CROCAS databases are the perfect inputs to our research, providing the broadest, most comprehensive collection of real-world negotiated trial costs that can be disaggregated and examined,” said Aylin Sertkaya, vice president of ERG in a press release.   

Cattie says this is the type of project that appeals to his group at Medidata. “We work on these types of engagements which kind of get away from the software side of our business on a consultative basis, and to be quite honest with you, we enjoy doing these,” he says. “We’re data geeks in the Trial Planning Solutions Group.”   

Read Kevin Davies’ interview with Medidata Solutions president Glen de Vries on the cloud, ‘omics, and personalized medicine. (January 2012).