ClinicalTrials.gov is a federally-run database of both publicy and privately funded clinical trials by American pharmaceutical companies. Companies are not required to either register their trials or disclose the results, as ClinicalTrials.gov is run on a voluntary basis. The penalties for failing to either register trials or submit results to ClinicalTrials.gov are either civil monetary penalties or the withholding of grants for federally-funded studies.
New legislation in the United States has been proposed to require clinical trials to be registered and both positive and negative results be disclosed within the database. This is in response to the recent $3 billion GSK settlement for civil and criminal charges for the company's failure to disclose data about Avandia, a diabetes pill that was associated with increased rates of heart attacks and strokes in unreleased company data.
Companies regularly suppress negative clinical trial results and exaggerate the benefits of drugs being tested. Similarly, unsuccessful trials and neutral results are not disclosed. The details of unsuccessful trials, as well as negative and neutral data are equally as, if not more, important than the positive clinical trial results, alone. Researchers and scientists can learn from published information on unsuccessful trials to perfect subsequent trial methods. Registered, disclosed, and published negative and neutral trial results are also valuable so that researchers know which trials have been conducted to avoid unnecessary and costly replication of studies. Furthermore, negative trial results are important, as this data may reveal why patient participants either did not benefit or were harmed by the clinical trial treatment.
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