Industry Calls For US FDA Transparency On Use Of Innovative Clinical Trial Designs
BIO and PhRMA ask agency to provide more guidance on trial implementation, data integrity and novel data sources.
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Pharma companies and associations cite numerous examples of getting inconsistent advice across review divisions, including the number of clinical trials required for rare disease drugs and acceptance of innovative clinical trial designs and novel endpoints.
Amgen exec calls for more informal agency feedback and alignment between review divisions in understanding design methodologies.
Final guidance provides more details on clinical trial designs that use Bayesian adaptive features; says monitoring committee recommendations may deviate from the anticipated algorithm.