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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

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 of investigational medicines, and that it was important to agree on a

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