What You Should Know About Patient-Centered Outcomes Interviewing: Instrument Development and Regulatory Submissions Requirements

The inclusion of patient and caregiver voices are increasingly valued in the process of collecting patient-centered data for regulatory submissions.
Interviewing plays a key role in exploring the patient experience and uncovering patients’ preferences and expectations for treatment (e.g., quality of life vs extended life). It requires sensitivity, and researchers must use an empathic approach to obtain rigorous scientific data from patients who are being medically treated and are often seriously ill. In this webinar, we will provide an overview of the increasing importance of the patient voice in regulatory approval. We will then discuss qualitative research methodologies used to gain patients’ and caregivers’ perspectives on disease/treatment factors that are relevant and important to them. We will conclude with case studies and highlight examples of how empathic, but rigorous, qualitative interviews can present patients’ and caregivers’firsthand experiences without bias.

Presented by: Angela Stroupe, Medical Anthropologist and Associate Scientist at Pharmerit specializing in Patient Reported Outcomes and Nicole Clarke, Senior Outcomes Research Manager at Pharmerit

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