Measuring tinnitus in pharmaceutical clinical trials.

This paper reviews methods and considerations for measuring tinnitus in clinical trials designed to evaluate treatment options using investigational medicinal products. Tests applied in tinnitus-related research and clinical practice have their own measurement purposes, advantages, and limitations. If the characteristics of each test method are well understood, the test can be effectively used in clinical trials. For the accuracy of clinical trial results, it is necessary to use a test tool with verified validity, reliability, and sensitivity. If a test tool that is likely to have high variability in the same individual is required in the clinical trial, strategies to increase the reliability of the test, such as repeat measurements, may also be needed. In addition, a test tool that meets the purpose of the clinical trial should be selected. For example, the tinnitus questionnaire is appropriate to assess reactions to tinnitus, and measurements of tinnitus loudness or pitch are appropriate to evaluate the psychoacoustic characteristics of tinnitus. In conclusion, the use of validated test tools that meet the purpose of the trial will help with the accuracy of the clinical trial results.