The article, Clinical trial results for FDA-approved drugs often remain hidden, a new study finds, was published on TranspariMed on July 29, 2021.
This article revolves around the study performed by a team of American researchers who examined 62 products by 42 pharma companies approved by the FDA in 2016-2017 and gives key insights on how clinical trial sponsors often violate a pre-eminent transparency law.
According to transparency law, applicable trials should be registered and made public within 21 days of their start date, and their results should be made public on the registry within 30 days of initial FDA approval of a product.
In the above study, it was found that amongst the 62 products, trials of 13 products did not consistently meet legal reporting requirements. At least one relevant trial result among the three-quarters of FDA-approved products still remains unrevealed. 42% of FDA-approved novel drugs and biologics fail to fully meet FDAAA reporting requirements.
While some big pharma companies are in compliance with the legal transparency requirement there are many other large companies that are still non-compliant. Out of 10,792 trials, there are around 2,800 currently missing trials. The authors of the study raise the question if FDA needs to widen its scope to address the products approved by the FDA by non-US-based companies and also suggests that the FDA may benefit from more stringent reinforcement of transparency law as it has not yet started to collect fines from the non-compliant sponsors.
While comparing the statistics to the European studies, an improvement in compliance was noted. However, after the EU Clinical Trial Regulation that would bind all European countries by the end of January 2022, it will be each country’s independent decision for whether and when to impose sanctions.
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