IN-TRIAL INTERVIEWS

Voice of the patient in clinical research

Use in-trial interviews in your clinical research for early insights on patient experience of new treatments, to understand patient relevance of novel endpoints, and to improve trial design.

Solutions Research & Development Consulting Patient Centered Solutions In-Trial Interviews

Collect Practical Feedback with Clinical Trial Interviews

In-trial interviews (ITIs), also referred to as clinical trial interviews, embedded interviews, or entry and exit interviews, is the methodology of conducting qualitative research with participants (patients and/or their caregivers) who are participating in a clinical research study. This may be in the context of a clinical trial that is testing a new healthcare intervention, or in an observational, real-world study.

IQVIA’s Patient Centered Solutions team is a global leader in the design and delivery of in-trial interviews with experience conducting nearly 100 clinical trial interview studies in over 50 indications, including with populations with psychiatric and neurological conditions, elderly and frail populations, adolescents and children, across Europe, the Americas, and Asia.

WHY USE IN-TRIAL INTERVIEWS?

FDA Requests for ITIs are on the Rise

In-trial interviews are frequently requested or recommended by the US Food and Drug Administration (FDA) to collect direct patient input that aids the interpretation of change on novel endpoints (usually those endpoints supported by a Clinical Outcome Assessment (COA)). FDA requests have driven a surge in interest in conducting interviews in phase 2 and phase 3 trials. However, as a methodology, clinical trial interviews can answer a wide range of research questions of interest to sponsors.

Data That Can Be Identified Via In-Trial Interviews

Treatment Experience

Qualitative view of treatment benefit to complement quantitative outcomes
Contextualize meaningfulness of outcomes from the patient perspective
Patient experience of side effects and tolerability
Understand individual benefit/risk assessment for the intervention

Intervention Data

Ease of using new device/treatment
Convenience and satisfaction with treatment regimen, potential barriers to uptake

COA Validation

Develop or confirm a conceptual model of the disease
Describe natural history and patient journey
Set foundation for instrument adaptation or development
Test content validity and establish responder definitions for a specific PRO/COA

Clinical Trial Protocol

Understand patient preferences for outcomes and treatments
Understand patient experience, needs and priorities during the clinical study

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Putting Clinical Trial Interviews into Action

IQVIA’s Patient Centered Solutions team is expert in the field of Patient Experience Data. Our scientists work with sponsors to design the interview study to meet the research objectives with careful consideration of the overarching clinical trial protocol. We then apply IQVIA’s global operational capabilities and commitment to the highest regulatory, compliance and data privacy standards to execute the clinical trial interview study.