Failure to Report Clinical Trials


When a new drug hits the market, doctors must trust that the government has appropriately tracked all clinical trial records to ensure its success.

On the other hand, the complete documentation of a prescription’s risks and benefits can also be detrimental to the safety of the patient, who must additionally trust that all possible outcomes of a drug have been reported.

However, when the most prestigious research institutions begin violating the federal law requiring public reporting of clinical study finds, who are these doctors and patients to trust?

This has been the case in a new STAT investigation, the first of its kind claiming that many leading universities and institutions and drug companies have routinely broken this law (http://www.statnews.com/2015/12/13/clinical-trials-investigation/).

This legislation was imposed to make sure those findings from human testing of drugs and medical devices were quickly made public through the website ClinicalTrials.gov and through the National Institute of Health (NIH). The law was additionally driven by concerns that the pharmaceutical industry had been hiding results in an attempt to make treatments appear safer and more successful overall.

Dangers of Nondisclosure

The reliance on robust clinical reporting is crucial because it sheds light on essential information which doctors must use to make appropriate treatment recommendations. With gaps in information being placed in the federal databases due to this law breaking, the effectiveness of a treatment cannot be accurately compared to its negative side effects.

Results from clinical trials are also used to determine what future studies need to be conducted to ensure the safety of the volunteers who participate in these trials. One extreme possible side effect of many drugs, suicidal thinking, makes this failure to report not only negligent and irresponsible, but exceedingly dangerous as well.

“Medical advances would not be possible without participants in clinical trials,” contended NIH director, Francis S. Collins, M.D., PhD, in a press release. “We owe it to every participant and the public at large to support the maximal use of this knowledge for the greatest benefit to human health. This important commitment from researchers to research participants must always be upheld.” (http://www.nih.gov/news-events/news-releases/hhs-nih-take-steps-enhance-transparency-clinical-trial-results)

SEE ALSO: The Age of Personalized Medicine

Institutions at Fault

Although a stigma has previously been attached to drug companies for failing to report such information, this investigation proved that major medical schools, teaching hospitals and nonprofits reported less results overall. Included in the institutions which have failed to report their findings are four of the top 10 recipients of federal medical research funding from the NIH: the University of Pennsylvania, the University of Pittsburgh, and the University of California at San Diego.

According to the investigation, these researchers, university administrators and hospital executives claim that they were not intentionally breaking the law. Instead, they attributed their selective compliance to a lack of time, administrative funding and the disclosure of some results instead through medical journals and conferences.

Yet equally concerning as their failures to report, STAT expressed that the federal government, including the FDA, has the power to suspend research funding and impose serious fines on all institutions which are determined to have neglected to disclose their trial results. If it chose to impose such sanctions, the government could have collected $25 billion from drug companies alone in the past seven years-yet the FDA has not authorized a single fine.

If institutions continue to refrain from reporting all clinical trial-related information, it is important that the government consider more stringent intervention. Without a full understanding of prescription effects, a serious danger is posed to human health and the public trust in the research system will surely dissolve.

Lindsey Nolen is a staff writer. Contact lnolen@advanceweb.com.

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