FDA Finalizes Risk-Based Monitoring Guidance with Practical Advice
(Thursday, April 13, 2023)
The final FDA guidance on risk-based monitoring (RBM) for clinical trials released this week expands on the advice given in the draft guidance from almost 10 years ago with a goal to reduce overall in-person site monitoring visits and increase reliance on centralized remote monitoring. Overall, this is not new information but confirmation of prevailing industry standards. Historically, clinical trial monitoring means 100% source data verification (SDV) during on-site visits by independent monitors. With electronic data and remote access, that is no longer necessary and efficient. Rather targeted risk-based monitoring of high-risk events provides a much better measure for the quality control of the clinical data. The FDA defines RBM as "a strategy that focuses on the risks that matter most to the quality and integrity of the trial results and to the protection of human subjects." RBM is much better geared towards identifying potential risks and timely mitigation than traditional monitoring methods. However, it is important that RBM be appropriately implemented. It starts with risk assessment to identify potential risks to subject safety and data quality, customized to a given trial. Once the risks have been identified, the sponsor should develop risk control strategies to mitigate those risks such as appropriate monitoring frequency, real-time centralized monitoring, and data analytics to detect potential issues. The above information should be included in the monitoring plan. FDA strongly recommends that the sponsor audit the trial operations early in the trial to verify that the RBM is working as expected and adjust when it is not. Also, the monitoring plans must be flexible to make needed adjustments as new information from the trial is collected. FDA’s guidance emphasizes that the quality of RBM depends on well-planned monitoring, use of technology such as electronic data capture (EDC) systems to collect data and implementing statistical monitoring for data analytics to identify issues early for timely mitigation. This would assure acceptable quality of the data with reduced on-site monitoring. Experience from the last 5+ years when RBM became increasingly popular, has demonstrated that it has the potential to improve data quality and subject safety while reducing monitoring burden and costs. However, it needs comprehensive planning based on risk assessment, customized to each trial, to be effective.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC