Italy Opens Up On Trial Woes In A Pandemic
Italian medicines agency chief Nicola Magrini recounts the problems AIFA faced and the lessons it learned through its work at the height of the coronavirus outbreak in Italy.
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Politicization of COVID-19 treatments is one of the unexpected wrinkles amid an unprecedented pandemic. But one lesson from the hydroxychloroquine experience in the US is more typical if still troubling: almost no one followed the rules on reporting follow-up data.
Coronavirus Update: Setback With Hydroxychloroquine, Slowdown In UK ADR Reports, But Novel Drugs Begin Trials
In addition to our daily in-depth coverage of key events relating to the coronavirus, we’re bringing you a periodic round-up of other pandemic developments. This edition covers events at the national, European and global level.
Based on experience from earlier epidemics, EU regulators are concerned that the high number of COVID-19 trials starting in a confined geography at the peak of the coronavirus pandemic will not be able to enrol patients up to their pre-established sample size.