ACTA welcomes back Adaptive Trial design expert Scott Berry to provide an overview of FDA guidance released for Adaptive Designs for Clinical Trials of Drugs and Biologics.
You can download a copy and read more about this document here: www.acta.cmail20.com/t/y-l-urelkd-tkdudtjriy-q
The guidance describes the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial and provides guidance to sponsors and applicants submitting investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or supplemental applications on the appropriate use of adaptive designs for clinical trials to provide evidence of the effectiveness and safety of a drug or biologic.
The draft guidance will replace the 2010 draft guidance for industry entitled 'Adaptive Design Clinical Trials for Drugs and Biologics.'
