Results of the analysis revealed that only 1.1 percent of total site-entered eCRF (electronic case report form) data are corrected as a result of SDV.
Published in the November issue of the Drug Information Association’s Therapeutic Innovation & Regulatory Science (TIRS) journal, the companies say the results of the analysis support the TransCelerate-proposed methodology for risk-based monitoring (RBM).
When compared to SDV, the analysis also showed that central monitoring activities and source data review (SDR) -- which 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. These findings generally support the conclusion that SDV should not be the primary data quality control method used in clinical trials.
Kyle Given of Medidata, an author of the study, told Outsourcing-Pharma.com that SDV is the “old school way of looking at” site data and now the industry is seeing “a large shift away from 100% SDV, supported by real time data and sound technologies that allow CROs to view risks so they can quickly do targeted SDV to see which sites and types of data are higher risk.”
Last year, the FDA made a similar proclamation, saying that “risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality.”
Given added that the conclusions around risk-based monitoring focus on the fact that transcription, or moving data from a medical chart to an EDC system, is going well “but what they do have a more difficult time managing is the identification of adverse events.” But he noted that sites are now working to obtain tools to look at data in more efficient ways.
Transcelerate has also offered its view on risk-based monitoring, focusing on the ways to use more centralized and off-site monitoring to help companies save money on site visits, as well as to enhance patient safety and data integrity.
Given added that there’s some apprehension in industry around pulling back from SDV as some are now saying, “what’s my support mechanism that I’ve had all of these years,” but Medidata and others are now working with companies to understand where their risks lie and including SDV around adverse events.