New ACRO Report Quantifies Benefits of RBM for Quality Reviews

A new report based on a survey of ACRO members reveals that Risk-Based Monitoring (RBM) makes clinical trial quality review more efficient and effective. The report, Establishing Risk-Based Monitoring within a Quality-Based System as “Best Practice” for Clinical Studies, found that when a company reviews data through a centralized system using the RBM model, CROs and technology companies are better able to detect quality issues earlier and make rapid corrections at the site level. This type of approach is now central to ensuring the safety of patients in clinical trials, and is expected to continue to grow in importance as clinical trials becomes more numerous and complex.

The report outlines specific improvements seen among individual ACRO members using this approach, such as a 17 percent better detection of significant deviations in trial data that could potentially indicate a risk to patient safety or other problem. Sponsors also reported the RBM approach expedited their quality-review process, helping them to submit trial data to the FDA sooner – and ultimately, it is hoped, to get needed therapies to patients more rapidly. ACRO continues to work closely with the FDA to encourage the uptake of RBM even more broadly across the industry. Read the full report here.

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