IH10 - Existing Guidelines for In-trial Interview Study Implementation: Towards Unified Interpretation
Information
The presentation explores the importance of integrating patient interviews into clinical trials while adhering to compliance standards and optimizing their contribution to regulatory submissions. It highlights key challenges in conducting patient interviews, such as risks of non-compliance, data rejection by authorities, and patient safety concerns.
By advocating for standardized processes, validated systems, and inspection-ready documentation, the presentation offers a framework for managing interviews throughout their lifecycle—design, conduct, analysis, reporting, and retention. Aligning these practices with ICH-GCP, ALCOA+ principles, and global data privacy regulations underpins consistent compliance and builds audit readiness. Crucially, it promotes elevating patient voice from anecdotal evidence to an integral component of robust regulatory evidence packages, enhancing the impact of patient-focused drug development and ensuring that interview data meets qualitative and regulatory standards.
