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15 Sponsors Participate in Study Evaluating Clinical Trial Procedures Tied to Study Endpoints and Objectives
NEW YORK, N.Y. – June 26, 2012 – The results of a new research study performed by researchers at the Center for the Study of Drug Development at Tufts University School of Medicine and sponsored by Medidata Solutions (NASDAQ: MDSO) found that clinical data gathered from 25 percent of the procedures administered to patients may be unnecessary – and, in the aggregate, are responsible for $3-5 billion in overall clinical trial costs annually.
With clinical trials increasing in complexity, cost and difficulty to execute, life science organizations are under growing pressure to identify opportunities to reduce costs and safely improve R&D efficiencies. Procedures identified as non-core to the protocol may represent opportunities for pharmaceutical companies to streamline their trials and significantly reduce clinical trial budgets.
Presented today by the study’s principal investigator Ken Getz at the Drug Information Association’s (DIA) Annual Meeting, the study was conducted over an eight month period and is based on data from 15 international sponsor companies of all sizes. Study participants and Getz’s team used a version of Medidata Designer® customized for the research study to collect and analyze more than 115 clinical trial protocols and categorize more than 22,000 medical procedures. The costs of “core” procedures – those supporting study end-points or safety objectives – and “non-core” procedures were measured using Medidata’s extensive benchmarked clinical trial cost database.
“This study is groundbreaking in that it links, for the first time, clinical trial economics to protocol complexity,” said Getz, senior research fellow and research assistant professor at CSDD. “The results have been eye-opening for participating companies and will no doubt serve as a jumping off point for pharmaceutical and biotechnology companies to examine ways to reduce the number of non-core procedures to improve clinical trial efficiency and substantially reduce study budgets.”
Key study findings include:
Marla Curran, director of clinical statistics and doctor of public health (DrPH) in biostatistics at GlaxoSmithKline (GSK), was part of the study working group and has driven efforts to increase efficiency across GSK trials. She views the study as one of the first to reveal actionable ways to cut clinical development costs without sacrificing safety or quality.
Medidata Designer was key to the Tufts CSDD team’s ability to collect information for the study, as it is the only tool to offer clinical trial sponsors visibility into cost and complexity metrics, as well as the structuring capabilities crucial for identifying unnecessary procedures during the study design stage.