The FDA’s draft guidance on adaptive design in clinical trials is a balanced, practical publication, according to the EVP of a CRO who expects the document to generate a “robust discussion”.
Adaptive designs have been identified as methods for improving the efficiency of the clinical trial process but there are concerns that some techniques can lead to bias. These concerns were highlighted in a recent paper in the Journal of the American Medical Association .
To help companies and regulatory agencies navigate this emerging area the US Food and Drug Administration (FDA) has drafted guidance which discusses the clinical, statistical and regulatory aspects of various adaptive design studies.