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.

中文翻译：

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四分体测试在临床对照试验辅助用品盲法评估中的应用

背景/目标：

确保 verum 和安慰剂无法在视觉上相互区分是盲法对照临床试验的一个关键方面。我们的目标是提出一种合理的方法来对安慰剂匹配候选者进行视觉评估。

方法：

Verum 和安慰剂样品是在透明的临床辅助用品（静脉内袋、注射器和给药管线）中制备的，使用不透明的袖子覆盖在不同的水平。Triangle 和 tetrad 测试是食品工业中广泛使用的两种感官辨别测试方法，用于评估 verum 和安慰剂之间的视觉差异。

结果：

三角形和四分体测试结果允许定义确保对三种具有治疗意义的生物药物分子进行盲法所需的不透明覆盖水平。虽然有限数量的小组成员不允许对三角形和四分体测试方法进行统计上的合理比较，但四分体测试在理论上具有比三角形测试更高的功效，这意味着需要更少的小组成员来得出相同的统计结论。

结论：

Tetrad 测试提供了一种合理的方法来定义受控临床试验中使用的辅助用品的盲法策略。