Dose escalations in phase I studies: Feasibility of interpreting blinded pharmacodynamic data.

Gerardus J Hassing Michiel Joost van EsdonkGerard J P van WestenAdam A Cohen Jacobus Burggraaf Pim Gal

Published in: British journal of clinical pharmacology (2022)

Our analysis showed that effect sizes <2× the between-measurement SD of the investigated outcome frequently go unnoticed by blinded reviewers, indicating that the weight given to these blinded analyses in current phase I practice is inappropriate and should be re-evaluated.

Keyphrases

study protocol
placebo controlled
primary care
healthcare
body mass index
electronic health record
weight loss
randomized controlled trial
clinical trial
quality improvement
weight gain