The QMN Weekly Bulletin

FDA GCP Inspections Increase; Violations Drop, Says 15-Year Study

Nov. 15, 2013

While the number of FDA inspections of clinical investigators has grown in the last 30 years, the proportion of objectionable findings has dramatically decreased, says a new report.

The number of clinical investigator inspections averaged 329 a year between 1997 and 2012 compared to an average of 235 a year between 1977 and 1996. That is due to an increase in the number of for-cause inspections in the U.S. and an increase in data-audit inspections in emerging market countries.

Despite the increase of those inspections, the number of data audit site inspections where the FDA did not require or ask investigators to take actions based on their observations increased to 55.8 percent between 2007 and 2011 compared to 16.9 percent between 1987 and 1991. For-cause inspections where no action was necessary jumped in the same time frame, from 3.8 percent to 38 percent.

For-cause inspections also tend to have more frequent deficiency reporting than data audit inspections. Inspections that result in “no action indicated” outcomes tend to happen in for-cause inspections at half the rate of data audit inspections. Conversely, instances where inspectors require corrective actions from investigators tend to happen eight times as often in for-cause inspections compared to data audit inspections.

The study, Guide to Global Clinical Trial Inspection Trends, was authored by Johan Karlberg, former director of the Clinical Trials Centre at the University of Hong Kong.

Karlberg also found in the past 15 years the number of citations against investigators for failing to follow protocol or keep adequate records remained steady at 32 percent and 23 percent, respectively.

By contrast, citations such as using inadequate consent forms, maintaining drug accountability and failing to report adverse drug reactions have individually dropped from 13 percent to about 4 percent over the same period.

The study also found more than a quarter of investigators are inspected more than once by the FDA and results generally improve during the second, third and fourth inspections.

Running a clinical trial is a major undertaking. You have to manage up to thousands of patients, sometimes in many different places around the world … and stay within regulatory good graces while you’re doing it. The Guide to Global Clinical Trial Inspection Trends will help you manage your trials, so reserve your copy now.