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Published Results Support Recommended Risk-Based Monitoring Methodology
Medidata (NASDAQ:MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced the results of a data-driven analysis conducted in collaboration with TransCelerate BioPharma Inc. ("TransCelerate"), which assesses the value of source document verification (SDV) in a risk-based approach to clinical trial site monitoring. Published in the November edition of the Drug Information Association’s Therapeutic Innovation & Regulatory Science (TIRS) journal, the results of the analysis support the TransCelerate-proposed methodology for risk-based monitoring (RBM), which can be adopted for different types, phases and stages of clinical trials.
Using robust operational data available through the Medidata Clinical Cloud®, the joint analysis explored the relative contribution of SDV—the process by which data within a case report form (CRF or electronic CRF) is compared to the original source of information—to overall clinical data quality. Results of the analysis revealed that only 1.1 percent of total site-entered eCRF data are corrected as a result of SDV, confirming that SDV has a minimal impact on overall data quality. Additionally, when compared to SDV, the analysis showed that central monitoring activities and source data review (SDR)—a process that involves checking the quality of the source data, reviewing protocol compliance and ensuring critical processes and source documentation are adequate—are of relatively higher overall value, supporting the conclusion that SDV should not be the primary data quality control method used in clinical trials.
“What we learned through our joint research initiative confirms that SDV is not effective at identifying systemic errors or substantially improving the quality of data gathered. These findings support the approach TransCelerate has outlined for high-quality RBM, which we believe will be an effective and efficient methodology for all organizations conducting clinical trials worldwide," said Dalvir Gill, TransCelerate’s CEO.
The analysis, titled “Evaluating SDV as a Quality Control Measure in Clinical Trials,” also reinforces the importance of applying effective centralized monitoring methods to ensuring quality, particularly with respect to reliably reporting adverse event data. This learning, as well as the other analysis results, is based on information collected from Medidata’s comprehensive business analytics solution Medidata Insights™, which comprises data—collected over the last five years—from over 7,000 clinical trials across the globe involving more than 110 sponsor organizations.
“We’re excited to share the results of the analysis and thrilled to be working on this important initiative with TransCelerate, an organization that is paving the way for life science companies to modernize and streamline the way clinical trials are conducted and monitored worldwide,” said Glen de Vries, Medidata’s president. “Over the last decade, Medidata has championed embracing a risk-based approach to the monitoring of clinical trial sites and the technology to apply it effectively. Doing so will enable sponsors and their CRO partners to make smarter trial decisions that reduce costs while supporting patient safety, data integrity and compliance.”
In addition to valuable benchmarking data and industry analytics, Medidata’s technology platform offers an easy-to-use, holistic solution to support RBM called Medidata RBM. The solution helps life science companies improve operational efficiencies, capture resource savings and enhance decision making throughout the trial lifecycle.
The largest initiative of its kind dedicated to improving drug development, TransCelerate—and member companies comprising most of the world’s leading, global life science R&D organizations—established five initial projects including the RBM initiative. Following draft guidance from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), TransCelerate released a position paper in June 2013 and anupdate in early 2014 outlining an approach for RBM. The framework provided includes tools and triggers to help the industry identify and categorize risks. (For more information, please visit http://www.transceleratebiopharmainc.com.)