Application of tetrad testing to the evaluation of blinding strategies for ancillary supplies used in controlled clinical trials

Abstract

Background/Aims:

Ensuring verum and placebo cannot be visually distinguished from each other is a critical aspect of blinded controlled clinical trials. Our objective was to propose a rational approach to the visual evaluation of placebo matching candidates.

Methods:

Verum and placebo samples were prepared in clear clinical ancillary supplies (intravenous bags, syringes and administration lines) covered at different levels using opaque sleeves. Triangle and tetrad tests, two sensory discriminative testing methods widely used in the food industry, were applied to assess visual differences between verum and placebo.

Results:

Triangle and tetrad test results allowed defining the level of opaque coverage required to ensure blinding for three biological drug molecules of therapeutic interest. While the limited number of panelists did not allow a statistically sound comparison of triangle and tetrad test methodologies, tetrad test has a theoretical higher power than triangle test, meaning fewer panelists are needed to reach the same statistical conclusion.

Conclusion:

Tetrad test offers a rational approach to define a blinding strategy for ancillary supplies used in a controlled clinical trial.