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June 5, 2012
BIMO Inspections Down 19 Percent From 2010, Most Sponsors Passing
The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than the year prior — with the decrease spread among all relevant agency centers as they move to a more risk-based approach.
The distribution and focus of inspections still looks generally the same as in prior years, despite the 18.8 percent drop in inspections, the agency’s May update to the Bioresearch Monitoring (BIMO) Initiative states.
The majority of inspections — 61 percent — targeted clinical investigators, while sponsors were the focus of just 141 inspections, about 15 percent. Inspections of institutional review boards (IRBs) accounted for 20 percent of all BIMO inspections.
CDER continued to dominate the distribution with 490 total inspections, just more than 50 percent of all BIMO inspections, followed by the Center for Devices and Radiological Health (CDRH) with one-third or 321 inspections and CBER with about 10 percent or 99 inspections (see chart below). The Center for Veterinary Medicine accounted for the remaining inspections.
CDER also conducted an additional 194 bioequivalence inspections that were not included in the 949 yearly total. This is a small jump from fiscal 2010 when 183 bioequivalence inspections were performed.
When determining which trials to inspect, all centers are increasingly relying on risk-based approaches. CDER is continuing to pilot a risk-based inspection model that allows for faster identification of sites for NDA-related inspections. The program has been used to select sites for more than a dozen NDAs and the center plans to expand its use. It is also developing a similar risk-based model to prioritize other inspection types, including inspections for sponsors, IRBs generic-drug applications.
CBER and CDRH also use early intervention, risk-based programs to identify studies for inspection.
Trial sponsors, contract research organizations (CROs) and monitors are typically meeting the FDA’s standards. Of the 127 sponsor inspection reports classified, 55 percent required no further action, up from 50 percent in fiscal 2010. In comparison, only 9 percent of sponsor inspections required further regulatory action.
Thirty-six percent of sponsor inspections revealed objectionable conditions that may warrant voluntary action on the part of the sponsor.
The most common sponsor violations were inadequate monitoring, failure to bring investigators into compliance, inadequate accountability for the investigational product and failure to obtain FDA and/or IRB approval prior to study initiation.
Meanwhile, five new guidances related to the work of BIMO and the Human Subject Protection initiatives are in development, the agency said. Draft guidances on informed consent, transferring clinical investigation oversight to a new IRB, protections for children enrolled in research and the core responsibilities of IRBs are forthcoming. The agency is also working on finalizing guidance on safety reporting requirement for INDs and bioavailability and bioequivalence studies.
The BIMO accomplishment report also includes a summary of the most recent regulations, guidances and other trial-related programs supported by the agency, such as the Clinical Trial Transformation Initiative. View the entire report at www.fdanews.com/ext/files/05-31-12-trials.pdf. — Sarah Karlin
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