A Practical Guide to Conducting In-Trial Patient Interviews

Regulators increasingly would like 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.

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

What this session covers

Our earlier session addressed compliance and provider requirements. This one focuses on the operational execution from the sponsor’s perspective. We will walk through the steps of defining interview objectives, project planning, preparation, and execution, with the primary focus firmly on the operational aspects. Analysis and reporting will be touched on, but the deep dive into those will be reserved for a future session.

We will discuss:

• embedding interviews directly in the main trial protocol
• timing interviews against both objectives and operational realities
• building an interview guide that is fit for purpose
• practical safeguards so no interviews are lost
• handling safety events that surface during an interview, with full traceability back to the trial

Where this fits in your work

Across clinical operations, safety, trial management, COA development, and strategic trial design, teams are increasingly being asked to incorporate the patient voice, and an efficient way of doing that is through in-trial patient interviews. If interviews are part of your trials, or you are exploring whether they should be, this session gives you a clear, operational picture of what it actually takes to run them compliantly, without overcomplicating 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.

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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