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.

Who Should Attend
This webinar will appeal to professionals at pharmaceutical and biotech companies working in:
Clinical Operations and Trial/Study Management
Patient Safety and Pharmacovigilance
Clinical Outcome Assessment (COA) and Patient-Reported Outcomes (PRO) development
Clinical Development and Trial Design Strategy
Patient Engagement and Patient Centricity
Regulatory Affairs and Medical Affairs
This also fits CRO professionals supporting sponsors with qualitative data collection in trials.

What You Will Learn
Attendees will gain insights into:
How to align interview objectives with evidence gaps and operational realities, from interview manual development through to preparing for analysis and reporting
How to schedule and track interviews so none are lost to practical obstacles, without burdening site staff and while staying compliant
How to build the operational documentation foundation: training requirements, essential documents and the agreements that keep the in-trial interviews running compliantly
What archiving looks like in practice: the regulatory requirements, the systems needed and the realities

Register free on Xtalks:
https://xtalks.com/webinars/a-comprehensive-guide-to-conducting-in-trial-patient-interviews/