Sequential Methods in Clinical Trials

Biases in clinical trials with sequential monitoring

Objectives It is well known that a sequentially monitored clinical trial that stops early for benefit has a crude treatment difference that overestimates the true treatment effect. This has led to extended debate in the literature, with some researchers arguing that early stopping is an important source of bias in meta-analyses of clinical trials. We therefore investigated the implications of e...

Statistical methods in clinical trials.

APPROPRIATE STATISTICAL METHODS for analysing trial data are critical for the correct interpretation of the results. Item 12 of the CONSORT statement (Box 1) relates to the statistical methods used in the reporting of trials, together with scientific and statistical principles concerning analyses of subgroups, endpoints and appropriate statistical tests. These issues need to be carefully consid...

On Certain Aspects of Sequential Clinical Trials

Group sequential designs for clinical trials.

Sequential Methods for Bivariate Survival Data in Clinical Trials : a Proposed Analytic Method

Sergio R. Munoz. Group Sequential Methods for Bivariate Survival Data in Clinical Trials: A Proposed Analytic Method. (Under the direction of Shrikant I. Bangdiwala and Pranab K. Sen) Interim analysis on accumulating data in clinical trials is usually done to assess whether there are significant differences between the experimental treatment under study and the control treatment in order to dec...