The U.S. Food and Drug Administration inspects many clinical trials as part of the drug approval process to ensure conformity to regulations. After inspecting the trials, the FDA classifies the trial based on the number or gravity of violations found.
Researchers examined 57 FDA-inspected clinical trials from 1998 to 2013 that had significant evidence for one or more of the following misconduct issues:
- Protocol violations (42 trials, 72 percent)
- Inadequate or inaccurate recordkeeping (35 trials, 61 percent)
- Failure to protect the safety of patients and/or issues with oversight or informed consent (30 trials, 53 percent)
- Falsification or submission of false information (22 trials, 39 percent)
- Violations not otherwise categorized (20 trials, 35 percent)
- Problems with adverse events reporting (14 trials, 25 percent)
Despite finding evidence of numerous violations, only three of the 78 publications (4 percent) that resulted from the 57 trials reported the objectionable FDA inspection findings.
According to the study authors, the FDA has an ethical responsibility to report the scientific misconduct it finds during its investigations and should make unredacted information readily available.
Additionally, journals should require study authors to be forthcoming and disclose any information regarding departures from good clinical practice to “help raise the standard for the reporting of research toward greater transparency.”
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