Qualitative data 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, and reveal outcomes that are most important to patients. Asking patients detailed questions about changes observed can provide insight into the “why” of a thought or feeling.
Patient interviews within clinical trials are a potentially rich source of data that are currently not widely conducted in the industry, although there is an emerging regulatory and industry interest in this methodology. Based on our experience across disease areas, the information collected during qualitative interviews can inform research, publication, communication, and regulatory submissions.
Dana DiBenedetti, Executive Director, Patient-Centered Outcomes Assessment at RTI Health Solutions (RTI-HS) shares, “We often get questions about using clinical-trial patient interviews. Helping clients fully understand their value is part of what we do.”
Greater Depth and Rationale
Interviews within the clinical trial setting can provide greater depth and rationale for a response given within the context of a traditional PRO measure, further describe treatment effects, and explain anomalous results. In some instances, regulatory agencies have suggested conducting qualitative interviews with patients to determine what outcomes are the most important and meaningful from their perspectives, in contrast with simply selecting an arbitrary endpoint.
To help drug and medical device developers understand this evolving methodology and its importance, RTI-HS researchers have written an article that delineates the types of data that may be collected during interviews with clinical trial participants. It outlines two approaches to conducting qualitative research in the clinical trial setting, with a focus on maximizing the value of the resulting data.
The article, Conducting Patient Interviews Within a Clinical Trial Setting, walks readers through several essential concepts.
- What are exit interviews?
- Why should they be done?
- When should they be done?
- What is the best method for conducting them?
The full manuscript is available as an open access document on RTI Press. Click to read –
Conducting Patient Interviews Within a Clinical Trial Setting
Dana B. DiBenedetti, T. Michelle Brown, Carla Romano, Claire Ervin, Sandy Lewis, Sheri E. Fehnel