Boston University and MIT Economists Leverage Medidata's Extensive Industry Data to Analyze Rising Cost of Drug Development
NEW YORK, N.Y. - March 30, 2011 - Medidata Solutions (NASDAQ: MDSO), a leading global provider of SaaS-based clinical development 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.
"The data Medidata is providing for this project-representing a cross-section of costs associated with government-funded studies and commercial R&D-are extremely hard to find and paramount to our success," said Dr. Iain Cockburn, one of the study's principal investigators. "R&D activities tend to be highly heterogeneous, which makes it difficult to compare meaningful year-to-year statistics across studies. With the data from Medidata Grants Manager and CRO Contractor, we are able to evaluate the wide range of components that go into the cost of a clinical trial, examine what happens to that cost over time and delve into the driving forces behind it."
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.
"Through innovative technology, as well as timely and accurate real world data, we are committed to helping our customers manage the costs and complexities of drug development-from trial concept to conclusion," said Tarek Sherif, CEO, Medidata Solutions. "We are excited that the data available through Medidata Grants Manager and CRO Contractor will enable the NBER-affiliated researchers to better understand cost factors in clinical trials, helping manage the economic impact of drug research and development on the economy at large."
About National Bureau of Economic Research
Founded in 1920, the National Bureau of Economic Research is a private, nonprofit, nonpartisan research organization dedicated to promoting a greater understanding of how the economy works. The NBER is committed to undertaking and disseminating unbiased economic research among public policymakers, business professionals, and the academic community. Over the years the NBER's research agenda has encompassed a wide variety of issues that confront our society. Early research focused on the aggregate economy, examining in detail the business cycle and long-term economic growth. Simon Kuznets' pioneering work on national income accounting, Wesley Mitchell's influential study of the business cycle, and Milton Friedman's research on the demand for money and the determinants of consumer spending were among the early studies done at the NBER.
About Medidata Solutions Worldwide
Medidata Solutions (www.mdsol.com) is a leading global provider of SaaS-based clinical development solutions that enhance the efficiency of customers' clinical trials. For over 10 years, Medidata has consistently brought next-generation innovation to the life science industry to lower the total cost of clinical development through informed trial planning and management, optimized clinical processes and platform interoperability. Medidata's advanced solutions address key functions throughout the clinical development process including protocol development (Medidata Designer®), trial planning and management (Medidata Grants Manager®, Medidata CRO Contractor®), user and learning management (iMedidataTM), randomization and trial supply management (Medidata BalanceTM), monitoring (Medidata Rave Monitor, Medidata Rave Targeted SDV), Serious Adverse Events capture (Medidata Rave Safety Gateway) and clinical data capture, management and reporting (Medidata Rave®). Our diverse customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.