UK MHRA: COVID-19 To Spark Rise In Clinical Trial-Related Deviations
The UK’s Medicines and Healthcare products Regulatory Agency says that any increase in clinical trial protocol deviations in relation to coronavirus outbreak will not constitute a serious breach.
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The coronavirus pandemic has thrown up unprecedented challenges for the Indian clinical trials segment, as in other parts of the world. Experts tell Scrip how things are poised in the country including potential impact on some critical milestones, but efforts are underway to tackle the crisis.
A protocol amendment is not needed to pause enrollment to decrease potential exposure to COVID-19, and virtual visits can be immediately implemented to ensure safety; experts say pandemic is forcing a rethinking in how companies carry out trials and in how regulators ensure patient safety and trial integrity.
Efforts are under way in the UK on many fronts to develop new treatments and vaccines for coronavirus infection, including researching new uses of existing products and clinical trials of new vaccines.