User login
Photo by Esther Dyson
A new study suggests that, when the US Food and Drug Administration (FDA) identifies problems at clinical trial sites, those findings are seldom reported in peer-reviewed articles later written about the research.
Only 4% of the articles analyzed in this study disclosed that an FDA inspection revealed significant problems at a trial site.
Charles Seife, of the Carter Institute of Journalism at New York University in New York, New York, reported this finding in JAMA Internal Medicine.
Seife noted that the FDA classifies its inspections based on the severity of the violations, and the most severe is “official action indicated (OAI),” which means objectionable conditions or practices that warrant regulatory action.
During the 2013 fiscal year, about 2% of the 644 inspections the FDA conducted at trial sites were classified as OAI.
With this in mind, Seife and his students set out to identify published trials in which an FDA inspection revealed significant problems and determine whether there was mention of it in the medical literature.
The group identified 57 trials in which an FDA inspection uncovered the following problems:
- Falsification or submission of false information (22 trials, 39%)
- Problems with adverse events reporting (14 trials, 25%)
- Protocol violations (42 trials, 74%)
- Inadequate or inaccurate recordkeeping (35 trials, 61%)
- Failure to protect the safety of patients and/or issues with oversight or informed consent (30 trials, 53%)
- Violations that were not otherwise characterized (20 trials, 35%).
Only 3 of the 78 publications (4%) that resulted from these trials mentioned the objectionable conditions or practices.
“The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds,” Seife wrote.
“The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.”
In a related editorial, Robert Steinbrook, MD, of the Yale School of Medicine in New Haven, Connecticut, and Rita F. Redberg, MD, of the University of California, San Francisco, wrote that Seife’s study highlights an important area for improved reporting of clinical trials and enhanced transparency at the FDA.
“A central responsibility of medical journals is maintaining and improving trust in the medical literature,” they wrote. “Journals should expect that investigators and sponsors of clinical trials would promptly notify them of substantial findings from FDA and other regulatory agency inspections and modify their reports of clinical trials as needed, either before or after publication.” 
Photo by Esther Dyson
A new study suggests that, when the US Food and Drug Administration (FDA) identifies problems at clinical trial sites, those findings are seldom reported in peer-reviewed articles later written about the research.
Only 4% of the articles analyzed in this study disclosed that an FDA inspection revealed significant problems at a trial site.
Charles Seife, of the Carter Institute of Journalism at New York University in New York, New York, reported this finding in JAMA Internal Medicine.
Seife noted that the FDA classifies its inspections based on the severity of the violations, and the most severe is “official action indicated (OAI),” which means objectionable conditions or practices that warrant regulatory action.
During the 2013 fiscal year, about 2% of the 644 inspections the FDA conducted at trial sites were classified as OAI.
With this in mind, Seife and his students set out to identify published trials in which an FDA inspection revealed significant problems and determine whether there was mention of it in the medical literature.
The group identified 57 trials in which an FDA inspection uncovered the following problems:
- Falsification or submission of false information (22 trials, 39%)
- Problems with adverse events reporting (14 trials, 25%)
- Protocol violations (42 trials, 74%)
- Inadequate or inaccurate recordkeeping (35 trials, 61%)
- Failure to protect the safety of patients and/or issues with oversight or informed consent (30 trials, 53%)
- Violations that were not otherwise characterized (20 trials, 35%).
Only 3 of the 78 publications (4%) that resulted from these trials mentioned the objectionable conditions or practices.
“The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds,” Seife wrote.
“The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.”
In a related editorial, Robert Steinbrook, MD, of the Yale School of Medicine in New Haven, Connecticut, and Rita F. Redberg, MD, of the University of California, San Francisco, wrote that Seife’s study highlights an important area for improved reporting of clinical trials and enhanced transparency at the FDA.
“A central responsibility of medical journals is maintaining and improving trust in the medical literature,” they wrote. “Journals should expect that investigators and sponsors of clinical trials would promptly notify them of substantial findings from FDA and other regulatory agency inspections and modify their reports of clinical trials as needed, either before or after publication.”
Photo by Esther Dyson
A new study suggests that, when the US Food and Drug Administration (FDA) identifies problems at clinical trial sites, those findings are seldom reported in peer-reviewed articles later written about the research.
Only 4% of the articles analyzed in this study disclosed that an FDA inspection revealed significant problems at a trial site.
Charles Seife, of the Carter Institute of Journalism at New York University in New York, New York, reported this finding in JAMA Internal Medicine.
Seife noted that the FDA classifies its inspections based on the severity of the violations, and the most severe is “official action indicated (OAI),” which means objectionable conditions or practices that warrant regulatory action.
During the 2013 fiscal year, about 2% of the 644 inspections the FDA conducted at trial sites were classified as OAI.
With this in mind, Seife and his students set out to identify published trials in which an FDA inspection revealed significant problems and determine whether there was mention of it in the medical literature.
The group identified 57 trials in which an FDA inspection uncovered the following problems:
- Falsification or submission of false information (22 trials, 39%)
- Problems with adverse events reporting (14 trials, 25%)
- Protocol violations (42 trials, 74%)
- Inadequate or inaccurate recordkeeping (35 trials, 61%)
- Failure to protect the safety of patients and/or issues with oversight or informed consent (30 trials, 53%)
- Violations that were not otherwise characterized (20 trials, 35%).
Only 3 of the 78 publications (4%) that resulted from these trials mentioned the objectionable conditions or practices.
“The FDA does not typically notify journals when a site participating in a published clinical trial receives an OAI inspection, nor does it generally make any announcement intended to alert the public about the research misconduct that it finds,” Seife wrote.
“The documents the agency discloses tend to be heavily redacted. As a result, it is usually very difficult, or even impossible, to determine which published clinical trials are implicated by the FDA’s allegations of research misconduct.”
In a related editorial, Robert Steinbrook, MD, of the Yale School of Medicine in New Haven, Connecticut, and Rita F. Redberg, MD, of the University of California, San Francisco, wrote that Seife’s study highlights an important area for improved reporting of clinical trials and enhanced transparency at the FDA.
“A central responsibility of medical journals is maintaining and improving trust in the medical literature,” they wrote. “Journals should expect that investigators and sponsors of clinical trials would promptly notify them of substantial findings from FDA and other regulatory agency inspections and modify their reports of clinical trials as needed, either before or after publication.”