Does publication of its Draft Industry Guidance, Oversight of Clinical Investigations—A Risk‐Based Approach to Monitoring, signal a shift in FDA’s philosophy of the monitoring of clinical studies for device approvals?
In the guidance document, FDA states it wants to make clear that "sponsors can use a variety of approaches to fulfill their responsibilities" and will encourage strategies that "reflect a modern, risk-based approach specifically encouraging greater use of centralized monitoring methods where appropriate."
With this draft guidance, FDA wants to clearly articulate and recognize the value of other monitoring approaches. What types of approaches are valued? As stated, FDA values approaches tailored to the complexity and challenges of the trials conducted, including needs of trial design, variability of study investigator training and experience, research site infrastructure, differences in standards of clinical care, and focusing upon the "most critical data elements" to provide a more effective monitoring strategy for the protection of human subjects and generation of quality study data.
The practical consensus places a greater emphasis on centralized monitoring strategies, whether those strategies are web based electronic data capture (EDC) or a statistical assessment of data to assess data trends and identify those sites at risk in terms of data quality. On-site data monitoring will remain an important aspect of clinical trial monitoring. The combination of remote and on-site monitoring strategies is critical to a risk mitigation approach for the successful conduct of investigational device clinical studies.
While remote electronic data capture systems offer greater immediacy and access to clinical site data, remote access for source document verification remains a limiting factor for a completely centralized approach. On-site monitoring offers the best approach for the prevention and identification of data fraud, early identification of data quality issues related to staff training, and comprehension of clinical study procedures and trial design. Will sponsors be quick to adopt more centralized approaches for data monitoring? While reduced costs associated with a reduced burden of on-site monitoring may appeal to many sponsors, FDA's demonstrated efforts to adjust and adopt its procedures will likely drive sponsor adoption of these new strategies.
How committed is FDA to these new approaches?
FDA has proposed that all related guidance documents -- updating BIMO compliance program guidance manuals for FDA staff, sponsors, CROs/monitors, and investigators - will be revised to encompass the new consensus for alternative monitoring approaches when the Risk Based Monitoring Guidance is finalized. In addition, FDA will encourage sponsors to submit their risk-based monitoring approaches to FDA for feedback as part of the pre-IDE process or through direct contact with CDRH's Division of Bioresearch Monitoring.
In the next installment, we will review the specific guidance recommendations for factors influencing data quality and integrity, general monitoring strategies, identification of critical data elements and processes to monitor, and factors to consider for development of a monitoring plan.