2024 - Beyond Numbers: The Value of In-Trial Interview Data for Regulatory and Health Technology Assessment (HTA) Decision-Making

Regulatory health authorities now recognize the significance and value of in-trial qualitative interviews in gaining greater insight into and understanding of the patient experience. These interviews provide supplementary data that can greatly enhance clinical trial design, interpretation of findings and product value for payers while addressing the unmet needs of patients. However, there is still a need for greater understanding regarding:
The utilization of qualitative evidence in drug development
How this evidence is valorized during evaluation by regulators and health technology assessment (HTA) bodies
Its implications for reimbursement decision-makers
In this webinar, the expert speakers will explore the added value of in-trial interview data in drug development and its pivotal role as a driver in decision-making for regulatory and HTA decisions. The discussion will draw from a range of identified case studies and findings from multiple data sources, including:
Food and Drug Administration (FDA) and European Medicines Agency (EMA) medicinal product labels: Reviews of in-trial interview data from 2017 to 2023
HTA Reports: Examination of products that include qualitative research in their drug development
Guidance Documents: Recent regulatory, HTA and other clinical guidance related to qualitative research
Attendees will be invited to participate in a pre-survey about their experience using in-trial data in regulatory and HTA submissions, the results of which will be presented during the webinar with key points addressed for knowledge-sharing.
Register for this webinar today to gain insights into how qualitative evidence enhances clinical trials, influences regulatory evaluations and affects health technology assessments and reimbursement decisions.
Keywords: Drug Development, Clinical Research, Patient-Centricity, Patient Recruitment, Patient Engagement, Clinical Data, Regulatory, Medical Affairs, HTA, HEOR, Commercialization/HEOR/Market Access