Regulators Insist On Large-Scale Trials For Coronavirus Treatment Candidates

Regulators Also Highlight Need To Preserve Supplies For Non-COVID-19 Uses

 
• By Ian Schofield
  
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At their second meeting on COVID-19, drug regulators from around the world have stressed the importance of large, multi-arm studies in generating the data needed for the approval of potential coronavirus therapies. The European Medicines Agency, which organized the meeting, has also announced a new coronavirus task force to identify promising drug candidates and help steer them through development to regulatory approval.

COVID-19
Large-scale randomized trials are key to finding coronavirus medicines • Source: Shutterstock

Medicines regulators from around the world are insisting that randomized, multi-arm clinical trials involving several agents are the best bet in terms of producing the data needed for rapid development and approval of potential COVID-19 therapeutics, and that such data needs to be shared at global level. They advise caution regarding the use of small-scale studies or compassionate-use programs.

They also warn that the “multitude” of clinical trials and medicines access programs currently under way could lead to shortages...

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