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
Secondary endpoints can be validly analyzed, even if the primary endpoint does not provide clear statistical
1Department of Biostatistics, University of North Carolina, Chapel Hill 27599-7400, USA.
Abstract:
Response variables from clinical trials are often divided into those considered primary and those considered secondary to the purposes of the study. If the difference between treatment groups on primary outcomes is not significant, the interpretation of significant differences in secondary response variables may be difficult because of multiple comparisons. It is proposed that the comparison on the primary outcome use a significance level of alpha and that the secondary endpoints be evaluated using a significance level alpha/(k + 1), where k is the number of secondary outcomes to be evaluated. Examples from recently completed clinical trials illustrate the use of this rule.
Related Concept Videos
Significance Testing: Overview
Effects of EDTA on End-Point Detection Methods
In the visual method, metal-ion indicators (metallochromic dyes), which have distinct colors in their free and complex forms, are added to the mixture to signal the titration's end point. They form stable complexes with metal ions, but these complexes are weaker than the corresponding metal–EDTA complexes. As a result, EDTA...
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...
Bioequivalence Data: Statistical Interpretation
Kaplan-Meier Approach
Assumptions of Survival Analysis