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.

Collect Practical Patient Feedback

In-trial interviews (ITIs), also referred to as 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 interview studies in clinical trials 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, 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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