Adaptive Clinical Trial Designs: US FDA Provides Checklist To Begin Study
Draft guidance specifies documentation that must be submitted to FDA prior to conducting an adaptive trial, and what to include in an application.
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Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.
Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.
Latin America Notebook: Advancing Adaptive Trial Designs, Translating ICH Guidelines, Sharing Confidential Information
Brazil's drug regulator ANVISA will require more experience in dealing with adaptive trial designs before issuing guidance; translating older ICH guidelines remains a barrier to their implementation; and industry is asked to be more transparent in sharing their confidential information among drug regulators to facilitate convergence.