For certain OTC switches, some of the most important regulatory questions are those concerned with consumers' ability to make an appropriate decision about the suitability of the drug for their own use. The self-selection study is an important, indeed often crucial, phase of label development.
Self-selection trials differ from label comprehension studies in some important ways. The nature of the respondent sample, the setting in which the testing is done, and the questions that are asked are designed to evaluate how potential OTC users of the drug will use the label in their selection decision.
These trials are more sophisticated than the earlier studies intended to determine whether members of the general population understand the wording of the label. They require a study design that allows participants to make the selection decision with only the information on the label to guide their choice. Moreover, the evaluation of that decision, with the various complicating factors that different individuals may possess, requires a careful assessment of the different way in which a participant may respond.
PEGUS has a great deal of experience designing, conducting, analyzing, and reporting self-selection trials, and has a cohort of sites available for placing such studies. We can help you formulate a self-selection strategy and design and conduct the studies needed to answer these key label development questions.
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