In the fiscal year of 2017, the Food and Drug Administration (FDA) performed over 900 inspections through the Bioresearch Monitoring (BIMO) Program. Of those 900 inspections, approximately 70% of the inspections targeted clinical sites. Without a doubt, there is some prediction about when and where the FDA will announce inspections during the course of clinical trial, both from the sponsor and the clinical sites.
So how does the FDA decide what sites to inspect? When it comes to inspections, the FDA has faced a number of growing challenges in recent years. The number of sites in a single clinical trial continues to rise. Additionally, clinical trials are becoming a more global affair with many sites located in foreign countries. With these challenges in mind, the FDA has been developing and implementing its Clinical Investigator Site Selection Tool (CISST). The primary goal of the CISST is to develop a science-based approach for site selection to ensure that even with limited resources, sites that pose the highest risk to public health are selected for inspection.
Jean Mulinde, senior policy advisor in the Office of Compliance, gave a presentation earlier this year explaining how the CISST is used to rank clinical sites by compiling data on a number of attributes submitted by sponsors to compile the “Clinsite” data set. Moreover, the FDA released a draft guidance in February 2018 outlining the electronic submission of data in standardized format for CDER (Center for Drug Evaluation and Research) to plan BIMO inspections. Overall, this data set includes both study-wide and site-specific information. At the study level, information includes data such as clinical trial type and design. At the site level, this includes information such as enrollment numbers, protocol deviation occurrences, adverse events, the Investigator track record with prior inspections, financial disclosures, and more. Once compiled, each category is then assigned a weight value and put through an extensive three-part calculation. The end result is an overall risk score, with the higher the score the more likely an inspection. The FDA can then utilize the risk score to determine if an inspection is warranted.
What does this all mean for clinical sites, sponsors, and CROs? As of right now, it is too early and there is not enough data to predict how this will change FDA inspection patterns or frequency. In the meantime, all players in a clinical trial should be prepared for a FDA audit at any time and be aware of the most common FDA violations that result in 483s and warning letters during BIMO inspections.
What strategies do you implement at the sponsor, CRO, or site level to be FDA inspection ready?Message From The Unseen World via photopin (license)