Simulation of various randomization strategies for a clinical trial in sickle cell disease.

ABSTRACT:

Objective

To use numerical simulation to evaluate various randomization strategies for a clinical trial in sickle cell disease (SCD).

Methods

The Inhaled Mometasone to Promote Reduction in Vaso-occlusive Events trial* is a randomized, controlled, feasibility study of inhaled mometasone for individuals with SCD who do not have asthma. The target sample size is 45 patients and one goal is to limit imbalance with respect to two important covariates (1) hydroxyurea use and (2) historical emergency department (ED) utilization. We compared three methods of patient allocation (simple randomization, block randomization, and biased-coin adaptive randomization) using numerical simulation (10 000 trials). The primary outcome measure was the proportion of simulated trials with numerical

SUBMITTER: Meurer WJ 

PROVIDER: S-EPMC5012429 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature