Viewpoints on the FDA draft adaptive designs guidance from the PhRMA working group.
The US Food and Drug Administration has recently released a draft guidance document on adaptive clinical trials. We comment on the document from the particular perspective of the authors as members of a PhRMA working group on this topic, which has interacted with FDA personnel on adaptive trial issue during recent years. We describe the activities and prior work of our working group, and use this as a basis to discuss the content of the guidance document as it relates to several issues of current relevance, such as data monitoring processes, adaptive dose finding, so-called seamless trial designs, and sample size reestimation.
Novartis, East Hanover, New Jersey, USA. paul.gallo@novartis.com
Paul
P
Gallo
Keaven
K
Anderson
Christy
C
Chuang-Stein
Vladimir
V
Dragalin
Brenda
B
Gaydos
Michael
M
Krams
José
J
Pinheiro
D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D017277:Drug Approval / Q000379:methods*; D054796:Drug Dosage Calculations; D017408:Guidelines as Topic; D006801:Humans; D015233:Models, Statistical; D015203:Reproducibility of Results; D012107:Research Design; D018401:Sample Size; D016896:Treatment Outcome; D014481:United States