Has the 2011 FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?

Jan 31, 2012
By Applied Clinical Trials Editors
Volume 21, Issue 1
Risk Based Monitoring Special Section

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Over the past year and a half we have been monitoring the trend towards adoption of risk-based monitoring across the industry, and in particular the move towards reduced source document verification (SDV). One might anticipate an imminent inflection point towards broader adoption of this paradigm given the FDA draft guidance and EMA reflection paper issued in 2011, which both strongly endorse the approach.

This month's featured Insights metric shows the trend in SDV Coverage from 2008 through 2012. The graph reveals a 7% decrease over the past five years from 92% down to 85%. So while this trend indicates a steady movement in the direction of risk-based monitoring, the progress has been relatively modest to date. The anticipated inflection point has not materialized yet following the 2011 FDA and EMA endorsements, at least from the perspective of SDV coverage. We will continue tracking this metric - along with other relevant metrics - through 2013 and beyond, and we fully expect an increasing downward slope in the SDV coverage trend moving forward as organizations move from piloting to broad implementation of risk-based monitoring. Previous analysis (http://bit.ly/IaqetC), shows that less than three percent of clinical data entered needs correction. Therefore, inefficient quality control procedures like non-targeted and 100% SDV coverage merely add costs and delays to the progress of clinical trials.

The broad adoption of electronic data capture systems like Medidata Rave® is decreasing the need for reliance on on-site monitoring, a move that is supported by the FDA's guidance. Clinical R&D organizations should therefore consider remote, centralized monitoring approaches and supporting technology solutions that enable verification of eCRF data at lower costs, yet do not compromise data quality.

How can SDV coverage be further decreased without impacting data quality? As always, Medidata is interested to hear your take on this result. Please stay tuned as we continue looking into clinical operations data from the more than 5,200 recent clinical trials found in the Insights metrics data warehouse.

- Medidata Solutions, www.mdsol.com

SDV coverage in Phase II/III studies, 2008-2012

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