USA – FDA eyes adaptive designs for BE studies impacted by COVID-19

The US Food and Drug Administration (FDA) is looking to adaptive designs to salvage in vivo bioequivalence (BE) studies that have been disrupted by the COVID-19 pandemic.

FDA acknowledged the impact that the public health emergency could have on BE studies early in the pandemic and in April 2020 the agency created a webpage with information for abbreviated new drug application (ANDA) sponsors noting that protocol revisions may be required for studies that are interrupted because of quarantines, site closures, travel restrictions or supply chain disruptions.

“Due to the challenges posed by the COVID-19 public health emergency on participation in BE studies, an adaptive study design may be a useful protocol revision for ANDA applicants,” FDA writes. “For example, an adaptive design may allow for additional subjects to be included in response to a larger than usual dropout rate.”…