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FDA CONDUCTED 316 INVESTIGATIONS OF CLINICAL RESEARCHERS IN 1989

Executive Summary

FDA CONDUCTED 316 INVESTIGATIONS OF CLINICAL RESEARCHERS IN 1989, FDA Division of Scientific Investigations Director Frances Kelsey, MD/PhD told a Food and Drug Law Institute conference on scientific misconduct April 17. "In fiscal 1989" (ended Sept. 30), Kelsey noted, "the agency did 316 investigations of clinical investigators of human drug studies and 73 investigations of veterinarian studies." The agency also conducted investigations of 141 non-clinical animal studies and 382 institutional review boards, Kelsey reported. FDA Center for Drug Evaluation and Research Medical Officer Bette Barton, MD/PhD, who also addressed the meeting, pointed out that FDA conducts an average of 200 to 250 routine data audits of clinical investigators per year. In addition, the division is responsible for 30 to 40 for-cause inspections, including foreign study inspections, and 10 to 20 bioequivalence inspections per year. Of the 2,261 routine inspections conducted from June 1977 to September 1989, 20% resulted in "squeaky clena" letters and 70% led to information letters, Barton said. FDA sent letters asking for an explanation after 7% of the investigations, while 3% required follow-up for-cause inspections, Barton noted. Among the 512 for-cause inspections carried out from June 1977 to August 1989, 365 were investigator oriented, Barton reported. She explained that the most common reasons for pursuing for-cause investigations of clinical investigators were either a follow-up to a previous investigation (35%) or from review division referrals (20%). The next major reason for a for-cause inspection was consumer complaints (16%), followed by a sponsor alerting FDA (10%) and a suspiciously large number of studies being conducted by one investigator (7%). Anomalous data (5%) and suspicious data (3%) ranked just above media attention (2.5%) as a reason for inspection. More than 50 investigators targeted for for-cause inspections have been disqualified by FDA since 1977. "On the average, from 1977 on we are disqualifying six investigators per year," Barton remarked. Barton also described several cheating methods used by investigators that have been uncovered during FDA inspections, including the use of reusable EKG files or reports, the falsification of patient visits, invented patient names, and fabricated consent forms. Some investigators have even gone so far as to take names from gravestones to complete their patient population, Barton remarked. The number of clinical investigator disqualifications may be on the increase, FDA Associate Chief Counsel for Enforcement Fletcher Campbell suggested at the meeting. Noting that "with the advent of the Reagan era a period of deregulation followed and there was much less in the way of investigator disqualifications," he predicted that "we are approaching the regulatory atmosphere [of] the late 70s [and] early 80s -- a period of more intense regulation."
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