NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that the U.S. Department of Health and Human Services (HHS) and consulting firm Eastern Research Group, Inc. (ERG) leveraged the robust operational data available through the Medidata Clinical Cloud® for a research-driven analysis on costs related to the design and execution of clinical trials. Published in the February 2016 edition of Clinical Trials: Journal of the Society for Clinical Trials, the analysis identifies different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the U.S. by clinical trial phase.
For their joint research, HHS and ERG utilized Medidata's extensive proprietary databases of negotiated investigator grants (PICAS® available through Medidata Grants Manager® and CROCAS® available through Medidata CRO Contractor®). The databases currently contain information from more than 331,000 negotiated site grants and contracts and 30,000 protocols in nearly 2,000 indications. Based on this comprehensive data, the research revealed that therapeutic area as well as number and types of clinical procedures involved are the key drivers of costs in Phase I through Phase III studies.
Aylin Sertkaya, vice president, ERG, added: "As the industry's largest repositories of real-world negotiated trial costs, Medidata's databases were vital to our research efforts. Analyses such as this support our goal of driving impactful change for the life sciences industry and the patients it serves."
Key research findings cited in the study include the following:
- Overall, the therapeutic area with the highest combined average per-study costs across Phases I, II and III is pain and anesthesia ($71.3 million), followed by ophthalmology ($49.8 million) and anti-infective ($41.2 million) trials.
- Trials in dermatology, endocrinology, and gastroenterology have the lowest overall costs across the same three phases.
- Overall, the top cost drivers of clinical trial expenditures across all three trial phases include those related to clinical procedures (15 to 22 percent), administrative staff (11 to 29 percent) and site monitoring (9 to 14 percent).
With their breadth of globally accessible real-world information, Medidata Grants Manager and Medidata CRO Contractor data solutions are widely used by pharmaceutical companies, contract research organizations (CROs) and academic researchers to identify prevailing rates for trial planning, budget development and grant negotiation. Uniquely, the PICAS and CROCAS databases available with these solutions contain hundreds of thousands of data elements—derived from actual negotiated contracts—that can be analyzed by therapeutic level, phase or geography, in easy-to-use, computer-based analytic tools.
"Medidata shares HHS and ERG's commitment to advancing clinical development so that safe new therapies can reach patients sooner," said Mike Capone, Medidata's chief operating officer. "We're proud that the rich data assets available through our platform supported this important research initiative, which will guide new strategies that help the industry transform drug development by optimizing clinical trial processes and reducing their costs."
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About U.S. Department of Health & Human Services (HHS)
HHS is the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. HHS represents almost a quarter of all federal outlays, and it administers more grant dollars than all other federal agencies combined.
About Eastern Research Group, Inc. (ERG)
ERG is a multidisciplinary professional services firm with a proven track record in delivering high-quality, technically sophisticated, and quick-response scientific, technical, and outreach support in the areas of policy and economic analysis, program assessment, evaluation studies, data collection and analysis, performance measurement, technical assistance, environmental and public health assessment, website and publication development. ERG's clients include the U.S. Department of Health and Human Services (DHHS); Agency for Toxic Substances and Disease Registry (ATSDR) and the Food and Drug Administration (FDA); as well as numerous offices and divisions throughout the U.S. Environmental Protection Agency (EPA), the U.S. Department of Energy (DOE), and the U.S. Occupational Safety and Health Administration (OSHA).
Medidata is the leading global provider of cloud-based solutions for clinical research in life sciences, transforming clinical development through its advanced applications and intelligent data analytics. The Medidata Clinical Cloud® brings new levels of productivity and quality to the clinical testing of promising medical treatments, from study design and planning through execution, management and reporting. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and contract research organizations.