Current Edition

Panel Recommends Device While Questioning Clinical Trial Change

The US Food and Drug Administration (FDA) allows for some
flexibility related to changes in clinical trial protocols—for example,
with adaptive trials. However, certain changes can lead to some
pointed questions from agency officials. Elizabeth Hollis, writer
and editor at Clarivate Analytics, explains how the FDA has also
provided its thinking on adaptive trials in joint guidance, titled
Adaptive Designs for Medical Device Clinical Studies, from
the Center for Devices and Radiological Health and Center for
Biologics Evaluation and Research. The guidance notes that an
adaptive design allows for prospectively planned modifications
as data are collected without weakening the study’s integrity and