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The role of data audits in detecting scientific misconduct. Results of the FDA program
1Department of Medicine, University of California, Los Angeles.
Abstract:
To evaluate the extent of the problem of scientific misconduct in investigational drug trials, we reviewed data from 1955 routine audits conducted by the US Food and Drug Administration (FDA) from June 1977 to April 1988. Serious deficiencies were detected in 12% of audits prior to October 1985, but in only 7% since that date. At the same time, there was no evidence of a decline over time in the rate of detection of many categories of deficiencies, and some investigators were able to continue to participate in drug trials after flagrant violations of recognized norms of research. The data auditing program should be continued, but additional measures are needed to regulate misconduct. These must be tailored to the variety of causes of misconduct, ranging from negligence to fraud. Possible additional approaches could include certifying the competence of potential investigators; peer-reviewed, competitive application for the opportunity to conduct FDA-authorized clinical trials; limiting an investigator's level of participation in clinical trials; penalizing manufacturers who fail to detect their investigators' misconduct; and permitting the FDA to suspend investigators prior to a hearing. Measures taken should maximize public utility at the least economic cost to society and should be evaluated thoroughly.
Insights
Scientific misconduct in drug trials was evaluated using US Food and Drug Administration (FDA) audits. While serious deficiencies decreased, ongoing issues necessitate enhanced regulatory measures for clinical trial integrity.
Area of Science:
- Medical Research Ethics
- Clinical Trial Oversight
- Regulatory Science
Background:
- Scientific misconduct poses a significant threat to the integrity of investigational drug trials.
- Routine audits by regulatory bodies are crucial for identifying deficiencies in clinical research.
- Historical data suggests persistent challenges in ensuring adherence to research norms.
Purpose of the Study:
- To assess the prevalence and trends of scientific misconduct in drug trials.
- To evaluate the effectiveness of existing auditing procedures.
- To propose improved regulatory strategies for clinical research.
Main Methods:
- Analysis of 1955 routine audit reports from the US Food and Drug Administration (FDA) between June 1977 and April 1988.
- Categorization and quantification of serious deficiencies identified during audits.
- Trend analysis of deficiency detection rates over time.
Main Results:
- Serious deficiencies were found in 12% of audits before October 1985, decreasing to 7% thereafter.
- No significant decline in the detection rate of many deficiency categories was observed.
- Some investigators with severe violations continued to participate in drug trials.
Conclusions:
- The FDA's data auditing program is valuable but insufficient on its own.
- Additional regulatory measures are required to address the spectrum of misconduct, from negligence to fraud.
- Recommendations include investigator certification, competitive trial applications, participation limits, manufacturer penalties, and expedited FDA suspension powers.