Embracing model-based designs for dose-finding trials.

ABSTRACT:

Background

Dose-finding trials are essential to drug development as they establish recommended doses for later-phase testing. We aim to motivate wider use of model-based designs for dose finding, such as the continual reassessment method (CRM).

Methods

We carried out a literature review of dose-finding designs and conducted a survey to identify perceived barriers to their implementation.

Results

We describe the benefits of model-based designs (flexibility, superior operating characteristics, extended scope), their current uptake, and existing resources. The most prominent barriers to implementation of a model-based design were lack of suitable training, chief investigators' preference for algorithm-based designs (e.g., 3+3), and limited resources for study design befo

SUBMITTER: Love SB 

PROVIDER: S-EPMC5537496 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature