Analysis of start-up, retention, and adherence in ALS clinical trials.

ABSTRACT:

Objective

To investigate predictors of trial start-up times, high attrition, and poor protocol adherence in amyotrophic lateral sclerosis (ALS) trials.

Methods

Retrospective analysis of start-up times, retention, and protocol adherence was performed on 5 clinical studies conducted by the Northeast ALS Consortium and 50 ALS clinical trials identified by PubMed search. Predictors of start-up times were estimated by accelerated failure time models with random effects. Predictors of retention and protocol deviations were estimated by mixed-model logistic regression.

Results

Median times for contract execution and institutional review board (IRB) approval were 105 days and 125 days, respectively. Contract execution was faster at sites with more ongoing trials (p = 0.005),

SUBMITTER: Atassi N 

PROVIDER: S-EPMC3806927 | biostudies-literature | 2013 Oct

REPOSITORIES: biostudies-literature