Qualitative In-trial Interviews: Methods, Challenges, and Best Practice.

Area of Science:

• Clinical Research Methodology
• Patient-Reported Outcomes
• Qualitative Research

Background:

• In-trial interviews provide rich patient experience data, complementing quantitative clinical trial endpoints.
• This data is crucial for understanding disease and treatment impact, validating assessments, and informing trial design.
• Published guidelines for conducting in-trial interviews are currently limited.

Purpose of the Study:

• To provide an overview of best practice methods for implementing in-trial interviews.
• To highlight the value of in-trial interview data in addressing specific research questions.
• To outline operational and logistical considerations for conducting in-trial interview studies.

Main Methods:

• Drawing on published examples and authors' experiences in conducting in-trial interview studies.
• Reviewing best practice methods for study design, sample size, interview conduct, and analysis.
• Outlining operational considerations including country/site selection, training, safety reporting, and data management.

Main Results:

• In-trial interviews generate insightful patient experience data.
• This data can inform regulatory decisions, health technology assessments, and clinical practice.
• Well-designed interviews provide evidence on product attributes and the patient impact of diseases and treatments.

Conclusions:

• In-trial interviews are a valuable methodology for capturing patient experience in clinical development.
• Adherence to best practices ensures the generation of high-quality, actionable data.
• This data significantly enhances the understanding of a product's real-world impact on patients' lives.