A Comprehensive Guide to Conducting In-Trial Patient Interviews

Regulators increasingly want to see the patient voice included to inform drug development, and in-trial patient interviews are one of the most direct ways to capture it. Done well, they transform patient experience into evidence that can support a regulatory submission. This webinar explains how to conduct patient interviews compliantly within a live clinical trial while meeting evidentiary and operational requirements.

With the increasing regulatory focus, the question is less often whether to include interviews and more often how to execute them compliantly within a live trial, where evidentiary standards and operational demands must be met simultaneously.

An earlier session addressed compliance and provider requirements. This session focuses on operational execution, covering the steps involved in defining interview objectives, project planning, preparation and execution, with a primary focus on operational considerations. Analysis and reporting will also be introduced, with a more detailed discussion reserved for a future session.

Across clinical operations, safety, trial management, COA development and strategic trial design, teams are increasingly being asked to incorporate the patient voice. For teams already incorporating interviews into clinical trials or evaluating their use, this session provides a clear operational view of what is required to conduct them compliantly without adding unnecessary trial complexity.

The speakers will discuss the importance of embedding interviews directly in the main trial protocol, how to balance and align the timing of the interviews with both objectives and operational realities, how to build an interview guide that is fit for purpose, how to ensure no interviews are lost to practical obstacles and how safety events raised during an interview are captured and traced back to the trial.

One theme runs through all of it: running compliant in-trial interviews that yield genuine insights is about dedicated expertise, structure, regulatory grounding and GCP-compliant systems built for the purpose.

Register for this webinar to learn how patient interviews can capture meaningful evidence while supporting compliant clinical trial operations.

Speakers

Jens Harald Kongsø, MSc in Economics, Founder and CEO, CLINIGMA®

Jens has 20 years of experience in Health Economics and Market Access at global pharmaceutical companies, supporting drug development from early stage through launch. With extensive experience in patient-reported outcomes across clinical trials, he founded CLINIGMA on the belief that statistical results alone cannot fully reflect what patients actually experience and value. Today, CLINIGMA is one of the leading providers of in-trial patient interviews, conducting interviews for global pharmaceutical companies in 35+ countries.

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Julie Perch, MA in Applied Cultural Analysis, Chief Operating Officer, CLINIGMA®

Julie leads the operational side of in-trial interviews at CLINIGMA. With over six years of hands-on experience running these projects across more than 16 pharma companies, she combines qualitative research expertise with deep operational knowledge and understands how the scientific and methodological dimensions of qualitative work shape the practical realities of running in-trial interviews. This experience has given Julie an intimate view of the sponsor side: the requirements, challenges and demands of running in-trial interviews in practice.

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Linda Nelsen, MHS in Epidemiology, Scientific Lead, CLINIGMA®

Linda is an experienced leader in Patient-Centred Outcomes and Clinical Outcome Assessment (COA), with a 30-year pharmaceutical industry career spanning PRO strategy, regulatory interactions supporting PRO endpoints, PRO development and patient engagement. Her leadership roles include Industry Co-Director of the Critical Path Institute’s PRO Consortium and Co-Chair of the ISOQOL Measuring What Matters Symposium. As Scientific Lead at CLINIGMA, she brings this sponsor-side experience to the design and conduct of in-trial patient interviews. She holds a Master’s Degree in Epidemiology from The Johns Hopkins University Bloomberg School of Public Health.

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