The FDA’s Final Risk-Based Monitoring Guidance and Beyond

The FDA has issued the final version of its risk-based monitoring guidance. In my view, this represents a milestone in industry and regulatory understanding of the extent to which electronic systems can increase the efficiency of clinical trials while maintaining data quality and patient safety. The guidance does not dismiss the value of site visits, but emphasizes the ways in which technology enables us to verify data without them. Health Decisions has long developed and refined techniques for remote monitoring. The FDA guidance describes a variety of remote monitoring techniques, including central statistical monitoring.

Checking the data that has already been collected, whether on site or remotely, whether through 100% SDV or selectively based on risk-based principles, is essential for ensuring data quality. But the benefits of looking backward are limited. Understanding the factors that contribute to data quality going forward is even more important. This is why our monitoring and trial management approach stresses continuous assessment of the predictive power of risk indicators during each trial. In our experience, continuously adjusted study-specific indicators provide a far more effective basis for trial management than generic indicators based on historical data for the therapeutic area or indication.

Another forward-looking technique is the use of inferred measures of site performance. Inferred measures reduce our dependency on what sites choose to report to the study team and when. Correlating inferred measures with data quality and site performance keeps us a step ahead, continuously improving operations rather than reacting to yesterday’s news.

A forthcoming article details an adaptive monitoring approach that incorporates risk-based principles but does much more, including use of inferred measures, continuous assessment of the predictive power of different risk indicators and adjustments to their relative contributions to the management metrics used to run each trial. Look for “Adaptive Monitoring: Risk-Based Monitoring and Beyond” in the September 1 issue of Journal of Clinical Research Best Practices

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