Questions in self‐selection studies used in consumer research for nonprescription drug candidates: Limitations and recommendations

Abstract

AbstractSelf‐selection studies assess participants' ability to use label information to decide if a proposed nonprescription drug is appropriate for their use. The optimal use of information from participants' responses in these trials has not been studied. Data from a self‐selection study for a progestogen‐only contraceptive pill (norgestrel 0.075 mg tablets, Opill) were analyzed. Participants (1772 evaluable participants) were provided with the proposed drug facts label and asked sequentially: (1) Given what you have read on the label and your own health history, is this product okay or not okay for you to take home today and start to use?; (2) Why or why not?; (3) Would you like to purchase Opill today to take home for your own use?; (4) Why or why not? The Per Guidance Analysis based on the US Food and Drug Administration's Guidance considered only the response to the first question as defining a selector. The Complete Analysis considered the responses to all four questions to determine a selector. The Per Guidance Analysis characterized 1597 participants as selectors, whereas the Complete Analysis identified 1180 participants as selectors. The decrease in selectors reflected participants who responded “okay” to the initial question but “no” to purchase question while providing rational explanations for their shift in responses. The results support the use of all available information when assessing a participant's intent in self‐selection studies for nonprescription drug candidates. The findings are discussed in the context of findings from the social cognitive and communication sciences.