A novel method to adjust efficacy estimates for uptake of other active treatments in long-term clinical trials.

ABSTRACT:

Background

When rates of uptake of other drugs differ between treatment arms in long-term trials, the true benefit or harm of the treatment may be underestimated. Methods to allow for such contamination have often been limited by failing to preserve the randomization comparisons. In the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, patients were randomized to fenofibrate or placebo, but during the trial many started additional drugs, particularly statins, more so in the placebo group. The effects of fenofibrate estimated by intention-to-treat were likely to have been attenuated. We aimed to quantify this effect and to develop a method for use in other long-term trials.

Methodology/principal findings

We applied efficacies of statins and other cardiova

SUBMITTER: Simes J 

PROVIDER: S-EPMC2798963 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature