NEJM Calls for Patient Data Transparency in Pharmaceutical Clinical Trials
In two papers that were published on Monday, the New England Journal of Medicine called for an international push for increased information sharing between pharmaceutical companies and members of the public.
MedPage Today reported on four different models for releasing patient data from clinical trials discussed in the journal, including an open access approach as well as one where the financier makes decisions for information releases on a case by case basis.
Transparency Efforts Aim to Mitigate Fiscal Risks and Increase Study Efficiency
On one side, the public, the scientific community, governmental regulators and sponsors would benefit from the sharing of information through public confidence in the industry and further falsifiability of studies. On the other side, pharmaceutical companies desire to protect trade secrets and proprietary concerns which allow companies a financial advantage over competition through their innovations.
The proposal for a managed-release of data would allow the sharing of patient-level data while maintaining individual privacy would allow a level playing field for stakeholders in pharmaceutical companies according to four officials from the European Medicines Agency.
According to Rita Redberg, professor of medicine at the University of California San Francisco, medical devices are often approved due to short-term clinical trials that have a provision that later down the line, companies will do long-term postmarketing studies; however, the data from such is often not published, preventing clinicians from providing accurate information on drug benefits and risks to patients.
The United Kingdom has proposed further oversight for trials financed under the National Health Service or public funding through demanding that findings from trials be published in a scientific journal whether they are positive or negative.
Statistics on Clinical Trial Study Transparency
According to one study published by members of Germany’s Institute for Quality and Efficiency in Healthcare (IQWIG), clinical trial information made available to the public contains less than half of the patient-relative data reported in unpublished Clinical Study Reports.
Data on benefits and adverse events related to drugs in 101 clinical trials were analyzed, showing that where there were 86 percent of unpublished records that contained complete reports on patient outcomes in drug studies while only 39 percent of publicly available sources contained complete information on patient outcomes.
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