Why did clinical trial registries fail to prevent Covid research chaos?
peter.suber's bookmarks 2022-05-17
"There is a long-standing global ethical obligation to register all trials before they start, shored up by regulatory requirements in some jurisdictions. Data from 18 registries worldwide feed into the WHO-managed International Clinical Trials Registry Platform (ICTRP), providing a continuously updated overview of who is researching what, when, where and how – at least in theory. If the registry infrastructure had worked and been used as intended, much of the COVID-19 research chaos would have been avoided. For example, researchers considering launching a hydroxychloroquine trial could have searched ICTRP and discovered that the drug was already being investigated by numerous other trials. Those researchers could accordingly have focused on investigating other treatment options instead, or aligned their outcome measures with existing trials. ... The global registry infrastructure has long been inadequately supported by legislators and regulators, and is woefully underfunded. This persistent neglect of the world’s only comprehensive directory of medical research led to costly research waste on an incredible scale during the pandemic. The WHO recommends that member states should by law require every interventional trial to be registered and reported. In addition, WHO recommends that all trial results should be made public specifically on a registry within 12 months, and that registry data should be kept up to date. By enforcing these three simple rules, regulators would ensure that there is a comprehensive, up-to-date global database of all trials and their results. In reality, existing laws in the EU and the US only cover a small minority of trials and are not being effectively enforced, while many other jurisdictions have no relevant laws at all. ..."
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