Practical recommendations for implementing a Bayesian adaptive phase I design during a pandemic.

ABSTRACT:

Background

Modern designs for dose-finding studies (e.g., model-based designs such as continual reassessment method) have been shown to substantially improve the ability to determine a suitable dose for efficacy testing when compared to traditional designs such as the 3 + 3 design. However, implementing such designs requires time and specialist knowledge.

Methods

We present a practical approach to developing a model-based design to help support uptake of these methods; in particular, we lay out how to derive the necessary parameters and who should input, and when, to these decisions. Designing a model-based, dose-finding trial is demonstrated using a treatment within the AGILE platform trial, a phase I/II adaptive design for novel COVID-19 treatments.

Results

We prese

SUBMITTER: Ewings S 

PROVIDER: S-EPMC8771176 | biostudies-literature | 2022 Jan

REPOSITORIES: biostudies-literature