Regulators Exchange Info On COVID-19 Vaccines, EU Urges Pooling Resources
WHO Will Start SOLIDARITY Trial Of Untested Treatments
Regulators are trying to keep sight of the bigger picture amidst disparate efforts to develop potential treatments and vaccines for the coronavirus outbreak. The World Health Organization and EU regulators are concerned that small individual studies may not be in the best interests of patients and are suggesting pooling resources.
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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.
Regulators held a virtual meeting to agree on the type and extent of preclinical data needed to inform the clinical development of vaccines for COVID-19.
New EU guidance on managing clinical trials in the context of COVID-19 requires sponsors to critically assess the feasibility of starting a new clinical trial or including new participants in an ongoing trial. A separate survey indicates that patient willingness to participate in new trials has dramatically declined due to the pandemic.