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

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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.

Speakers

Carla Dias-Barbosa, MSc, Senior Research Leader & In-trial Research Lead, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Ms. Carla Dias-Barbosa has over 20 years of experience in the patient-centered research field. She leads Evidera’s in-trial research business and is responsible for the coordination of the team’s training activities, in-trial research process optimization as well as development of best practices for the design, implementation and analysis of in-trial research within Evidera.

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Miriam Kimel, PhD, Senior Research Scientist, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Dr. Miriam Kimel has over 20 years of experience in qualitative and quantitative patient-centered studies, including planning, implementing and analyzing exit/in-trial research studies. She has led multiple in-trial research studies across countries, indications and designs. She has recently worked to develop internal tracking systems to streamline in-trial study management processes, including participant recruitment, site training and interview scheduling and conduct.

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Karen Bailey, PhD, Research Scientist, Patient-Centered Research, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Dr. Karen Bailey brings thirteen years of research experience, delivering qualitative and quantitative patient-centered studies across multiple therapeutic areas, including rare diseases, oncology, mental health, drug and alcohol use and social inequalities. Dr. Bailey currently leads a number of exit/in-trial interview studies, using mixed-method research design and longitudinal qualitative research approaches.

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Paulina Rolska-Wójcik, PhD, Director, Value & Access Consulting, Evidera, part of the PPD clinical research business of Thermo Fisher Scientific

Dr. Paulina Rolska-Wójcik has over eleven years of healthcare experience spanning industry and consulting. In her current role at Evidera, she is actively involved in various types of projects, including integrated scientific advice, HTA landscape assessments and projects related to EU HTA regulations for global and local pharma teams.

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Acknowledgement of additional contributors:

Mona L. Martin, Olabimpe Ruth Eseyin, Caroline Delaitre-Bonnin

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