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The World Health Organization (WHO) and the International Federation of Drug Regulators (ICMRA) issued a joint statement on May 7, calling on the pharmaceutical industry to increase transparency in reporting and providing clinical trial data.
The World Health Organization (WHO) and the International Federation of Drug Regulators (ICMRA) issued a joint statement on May 7, calling on the pharmaceutical industry to increase transparency in reporting and providing clinical trial data.
The two agencies pointed out in the statement that “for the sake of overriding public health interests, clinical trial reports should be released directly without compiling confidential information”, calling on pharmaceutical companies to report clinical trial results instead of compiling confidential information for commercial reasons.
The statement stated that “in any case, aggregated data is unlikely to lead to re-identification of personal data, and anonymization technology can be used.
In addition, if negative trials are not published, the scientific literature is incomplete.
The statement pointed out that the public health emergency of the new crown pandemic has stimulated the need for global cooperation and information sharing.
The statement pointed out that despite the multilateral efforts, "not all past efforts have been successful", usually because they cannot be sustained due to reliance on goodwill or lack of appropriate resources.
In the United States, despite the FDA Amendment Act (FDAAA) in 2007 and the final regulations in 2016, clinical trial sponsors were formally required to register and report trial results.
Although the FDAAA imposes civil penalties on sponsors who fail to report clinical trial results, the FDA’s enforcement has been weak.
Finally, WHO and ICMRA also pointed out that another benefit of more transparent clinical trial data may be increased public trust in the required therapeutic drugs and vaccines.
In consideration of public health benefits, WHO and ICMRA call on the “pharmaceutical industry to make a commitment within a short time frame (don’t wait for legal changes) to provide voluntary and unrestricted access to trial results data.