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Executive Summary

SCIENTIFIC MISCONDUCT IN INVESTIGATIONAL DRUG TRIALS has declined in severity since 1985, according to an analysis of 1,955 routine audits conducted by the FDA. The analysis of the audits is reported by Martin Shapiro, University of California at Los Angeles, and Robert Charrow, in the May 5 Journal of the American Medical Association. Charrow was until recently HHS Deputy General Counsel. Shapiro and Charrow examined 1,955 audits that FDA conducted from June 1977, when the audit program began, to April 1988. They found that "serious deficiences were detected in 12% of audits prior to October 1985, but in only 7% since that date." At the same time, they state, "a variety of specific deficiencies continues to be detected by the auditors." For instance, they note that the rates of protocol nonadherence and inaccurate records have not declined. "Problems with adherence to research protocols were reported in 25% of audits prior to October 1985, compared with 27% since that date," the report states. "Similarly, the rate of detection of inaccurate records has remained above 20%." The authors also point out that "an appreciable number of investigators whose audits revealed serious deficiencies, and who were engaging in scientific misconduct," were not disciplined. The report explains that misconduct by researchers went unpunished "either because their offenses were judged to be nondeliberate or because they promised not to do it again." Of 395 for-cause audits completed from June 1977 to April 1988, 84% did not lead to disqualification or restriction, the authors note. Seventeen investigators (4%) "who had repeatedly and deliberately violated regulations and who engaged in scientific misconduct" told FDA they would not continue such practices, and they avoided disqualification. The authors point out that FDA recently revised its policies and regulations and has begun to disqualify some investigators despite pledges to follow more rigorous procedures in the future. Shapiro and Charrow deemed FDA's data program to be important, but they offered five additional options to regulate misconduct. They proposed (1) requiring certification of clinical investigators by FDA or another appropriate body; (2) awarding research contracts through competitive application; (3) limiting the number of subjects that a physician can enroll in a study; (4) penalizing manufacturers for misconduct by investigators; and (5) suspending investigators prior to a hearing. The authors conclude that data audits have a role in monitoring investigational drug trials. They say it would be inappropriate to generalize this finding to other forms of research, "particularly to basic biomedical research." Such audits may not be feasible because clinical drug trials are very different from the basic or discovery research generally funded by NIH and the Alcohol, Drug Abuse and Mental Health Administration, the report suggests. In addition, a data audit program could stifle scientific creativity and institutionalize conformity.

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