Plan Patient Interviews to Strengthen Trial Data Readiness

Speaker(s): Jens Harald Kongsø & Christian Holm

The FDA and EMA increasingly appreciate seeing how the patient voice has been incorporated to inform drug development. In-trial patient interviews are one of the most direct ways to capture it. But generating data that withstands regulatory scrutiny starts long before the first interview is conducted. This webinar explores how patient interviews can be planned from the outset to support regulatory expectations and produce usable clinical trial data.

Getting the planning right matters more than most teams realize. There are many practical pitfalls, hurdles and dependencies, each of which can jeopardize the collection of the in-trial interviews if not done correctly. Additionally, there are also many requirements to live up to, in order to ensure that the patients’ safety is secured and that the interviews can be trusted when they are submitted to the regulatory bodies.

This is the first in a four-part webinar series covering the full lifecycle of in-trial patient interviews. This opening session focuses on what to be mindful of when planning in-trial interviews: what the FDA and EMA guidance requires, what has changed with recent ICH-GCP guideline updates and what patient safety and data integrity mean in practice before a single interview begins. The featured speakers will walk through the most common planning mistakes and what a structured, compliant approach looks like.