DiBenedetti DB, Brown TM, Demuro CJ, Ervin C, Lewis SA, Fehnel SE. Conducting patient interviews within a clinical trial setting. RTI Press. 2018 Aug.


Qualitative data centered on patients' experiences and perspectives typically go uncollected in clinical trial settings. Yet patients' treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in traditional patient-reported outcome questionnaires. Qualitative interviews can capture patients' perceptions of treatment needs, more fully explore meaningful changes experienced as a result of treatment and reveal outcomes that are most important to patients. Asking patients detailed questions can provide insight into the "why" of a patient's expressed thought or feeling. The inclusion of patient interviews within clinical trials is a relatively new and evolving field of research. This article delineates the types of data that may be collected during interviews with clinical trial participants and outlines two approaches to conducting qualitative research in the clinical trial setting, with a focus on maximizing the value of the resulting data.

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