Even federal agencies are feeling the consequences of increased transparency as studies uncover serious problems in how data from clinical trials is made available to the public
Increased transparency is coming to clinical trials because of proposed new federal rules. Although the greatest impact will be on drug trials and pharmaceutical research, experts believe that developers of new diagnostic technologies and clinical laboratory tests will benefit as a result of easier access to the public data filed by researchers. Two government agencies published notices announcing their intention to stiffen requirements for greater transparency in clinical trials. The proposed changes are significant for pathologists and medical laboratory professionals because, more stringent requirements for registration and dissemination would make more data from clinical studies available for researchers who develop clinical laboratory tests.
HHS and NIH Publish Notice of Proposed Changes
In November 2014, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making (NPRM). The same month, its research agency, the National Institutes of Health, announced a draft policy regarding required dissemination of NIH-funded clinical trial information.
The goal of the proposed changes is to ensure that summary results for drugs that fail in trials, or are dropped for other reasons, still make it into the public database, ClinicalTrials.gov, according to a story published in Science.
“This proposed rule would close an important gap, making additional information about clinical studies of investigational drugs, medical devices, and biological products available to the public,” stated Commissioner Margaret A. Hamburg, M.D., Commissioner of the Food and Drug Administration (FDA), in a recent NIH news release. The FDA is the HHS agency charged with enforcing regulations to protect human subjects and to ensure scientific integrity in clinical trials.
JAMA Editorial Blasts FDA for Ignoring Faulty Science and Fraudulent Behavior in Clinical Trials
In its February 9 issue, the Journal of the American Medical Association Internal Medicine (JAMA) published a criticism of the FDA’s failure to ensure transparency in clinical trials. The author of the editorial was New York University (NYU) journalism professor, Charles Seife.
Seife and his investigative reporting class at NYU had conducted an investigation to determine the extent of alleged FDA misconduct regarding lack of transparency in clinical trials. Seife criticized the FDA for repeatedly hiding evidence of scientific fraud from the public.
“For an agency devoted to protecting the public from bogus medical science,” declared Seife in JAMA, “the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.”
National Institutes of Health Director Francis Collins, M.D., Ph.D., (on left) recently called the track record on disseminating clinical trial results “disappointing,” according to a Wall Street Journal report. New York University Professor of Journalism Charles Seife (on right) conducted a study of the U.S. Food and Drug Administration’s transparency in the dissemination of results of clinical trials. His findings showed a high incidence of the agency’s failure to publicly reveal instances of misconduct, including violations that brought into question the reliability of the study findings. (Photo copyrights National Institutes of Health and National Association of Science Writers respectively)
Study Points to FDA Pattern of Concealing Misconduct
The study team looked at FDA documents on roughly 600 clinical trials. The cases had all failed FDA inspections. Due to heavy FDA redaction, the Seife team could only identify the specific study, drug, and pharmaceutical company in less than 17% of the trials. In the remaining 83%, the FDA succeeded in shielding the responsible drug maker and study sponsor from public exposure, according to Seife.
Seife’s team found that an FDA inspection of the trial site revealed one or more problems in 57 of the trials, according to the editorial. The violations ranged from falsification of adverse events reporting, to protocol violations and failure to protect the safety of patients.
Seife also sharply criticized the FDA in a story published in Slate. “When the FDA finds scientific fraud or misconduct, the agency doesn’t notify the public, the medical establishment, or even the scientific community that the results of a medical experiment are not to be trusted. On the contrary, for more than a decade, the FDA has shown a pattern of burying the details of misconduct.”
The Seife study also revealed that less than 50% of NIH-funded clinical trials had expediently published their results in a peer-reviewed biomedical journal. According to ClinicalTrials.gov, most clinical trial results must be submitted no later than 12 months after completion.
Failure to Disseminate Complete Clinical Trial Findings
A study at Yale University drew similar conclusions. “When research findings are not disseminated, the scientific process is disrupted and leads to redundant efforts and misconceptions about clinical evidence,” stated first author, Joseph Ross, M.D. Ross is Assistant Professor of Medicine, at Yale. His comments appeared in a Yale news release. “Such inaction undermines both the trial in question and the evidence available in peer-reviewed medical literature. This has far-reaching implications for policy decisions, and even institutional review board assessments of risks and benefits associated with future research studies.”
The findings of the Ross study appeared in the January issue of British Medical Journal (BJM).
It is likely that most professionals working in laboratory medicine were unaware of these multiple studies that revealed the extensive problems in how clinical trials data is handled by different federal agencies. In this regard, increased transparency is catching government regulators falling short of their statutory responsibilities.
More specific to laboratory medicine, much of the clinical trial data about the development of therapeutic drugs could help pathologists and academic pathology departments that conduct research into useful biomarkers. Such data could lead to medical laboratory tests that can better detect disease and identify the most appropriate therapies for an individual patient. Thus, the laboratory medicine profession could benefit from expanded access to complete, reliable clinical study data.
—Pamela Scherer McLeod
Related Information:
Clinical Trials Registration and Results Submission
Many NIH-Funded Clinical Trials Go Unpublished Over Two Years After Completion
Reporting Research Misconduct in the Medical Literature
HHS and NIH Take Steps To Enhance Transparency of Clinical Trial Results
Announcement of a Draft NIH Policy on Dissemination of NIH-Funded Clinical Trial Information
What Happens When Results Data from Clinical Trial Results Goes Missing?
