Related Experiment Video
Updated: Aug 17, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Statistical methods for monitoring clinical trials
1National Heart, Lung, and Blood Institute, Bethesda, Maryland 20892-7938, USA.
Abstract:
Clinical trials are monitored to determine whether a treatment is safe and effective. If it becomes clear that treatment is superior to control, ethical considerations compel us to stop the study and make the treatment available to control patients. On the other hand, if it becomes clear that the treatment will not be shown superior to control, we would like to stop the study and save valuable resources for more promising agents. But how much evidence is enough to declare benefit, and what criteria do we use to stop for lack of benefit? This article reviews monitoring procedures designed to answer these two questions. The B-value approach of Lan and Wittes (1) and Lan and Zucker (2) is used to unify the monitoring of many different kinds of trials, including those with continuous, dichotomous, or survival outcomes.
Related Concept Videos
Clinical Trials
There are four phases in a clinical trial. A phase one...
Clinical Trials: Overview
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Therapeutic Drug Monitoring: Drug Analysis Methods
Statistical Methods for Analyzing Epidemiological Data
Statistical Software for Data Analysis and Clinical Trials
