Evaluation of agile designs in first-in-human (FIH) trials--a simulation study.

ABSTRACT: The aim of the investigation was to evaluate alternatives to standard first-in-human (FIH) designs in order to optimize the information gained from such studies by employing novel agile trial designs. Agile designs combine adaptive and flexible elements to enable optimized use of prior information either before and/or during conduct of the study to seamlessly update the study design. A comparison of the traditional 6 + 2 (active + placebo) subjects per cohort design with alternative, reduced sample size, agile designs was performed by using discrete event simulation. Agile designs were evaluated for specific adverse event models and rates as well as dose-proportional, saturated, and steep-accumulation pharmacokinetic profiles. Alternative, reduced sample size (hereafter referred to as agil

SUBMITTER: Perlstein I 

PROVIDER: S-EPMC2782075 | biostudies-literature | 2009 Dec

REPOSITORIES: biostudies-literature