Ilaria Durosini1, Rosanne Janssens2, Reinhard Arnou2, Jorien Veldwijk3,4, Meredith Y Smith5, Dario Monzani1,6, Ian Smith4, Giulia Galli7, Marina Garassino7, Eva G Katz8, Luca Bailo1, Evelyne Louis9, Marie Vandevelde9, Kristiaan Nackaerts9, G Ardine de Wit4, Gabriella Pravettoni1,6, Isabelle Huys2. 1. Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy. 2. Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium. 3. School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands. 4. Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands. 5. Alexion Pharmaceuticals, Inc., University of Southern California School of Pharmacy, Los Angeles, CA, United States. 6. Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy. 7. Unit of Thoracic Oncology, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. 8. Janssen Research and Development, Raritan, NJ, United States. 9. Department of Pneumology/Respiratory Oncology, University Hospital Leuven, KU Leuven, Leuven, Belgium.
Abstract
Introduction: Lung cancer is the deadliest and most prevalent cancer worldwide. Lung cancer treatments have different characteristics and are associated with a range of benefits and side effects for patients. Such differences may raise uncertainty among drug developers, regulators, payers, and clinicians regarding the value of these treatment effects to patients. The value of conducting patient preference studies (using qualitative and/or quantitative methods) for benefits and side effects of different treatment options has been recognized by healthcare stakeholders, such as drug developers, regulators, health technology assessment bodies, and clinicians. However, evidence-based guidelines on how and when to conduct and use these studies in drug decision-making are lacking. As part of the Innovative Medicines Initiative PREFER project, we developed a protocol for a qualitative study that aims to understand which treatment characteristics are most important to lung cancer patients and to develop attributes and levels for inclusion in a subsequent quantitative preference survey. Methods: The study protocol specifies a four-phased approach: (i) a scoping literature review of published literature, (ii) four focus group discussions with stage III and IV Non-Small Cell Lung Cancer patients, (iii) two nominal group discussions with stage III and IV Non-Small Cell Lung Cancer patients, and (iv) multi-stakeholder discussions involving clinicians and preference experts. Discussion: This protocol outlines methodological and practical steps as to how qualitative research can be applied to identify and develop attributes and levels for inclusion in patient preference studies aiming to inform decisions across the drug life cycle. The results of this study are intended to inform a subsequent quantitative preference survey that assesses patient trade-offs regarding lung cancer treatment options. This protocol may assist researchers, drug developers, and decision-makers in designing qualitative studies to understand which treatment aspects are most valued by patients in drug development, regulation, and reimbursement.
Introduction: Lung cancer is the deadliest and most prevalent cancer worldwide. Lung cancer treatments have different characteristics and are associated with a range of benefits and side effects for patients. Such differences may raise uncertainty among drug developers, regulators, payers, and clinicians regarding the value of these treatment effects to patients. The value of conducting patient preference studies (using qualitative and/or quantitative methods) for benefits and side effects of different treatment options has been recognized by healthcare stakeholders, such as drug developers, regulators, health technology assessment bodies, and clinicians. However, evidence-based guidelines on how and when to conduct and use these studies in drug decision-making are lacking. As part of the Innovative Medicines Initiative PREFER project, we developed a protocol for a qualitative study that aims to understand which treatment characteristics are most important to lung cancerpatients and to develop attributes and levels for inclusion in a subsequent quantitative preference survey. Methods: The study protocol specifies a four-phased approach: (i) a scoping literature review of published literature, (ii) four focus group discussions with stage III and IV Non-Small Cell Lung Cancerpatients, (iii) two nominal group discussions with stage III and IV Non-Small Cell Lung Cancerpatients, and (iv) multi-stakeholder discussions involving clinicians and preference experts. Discussion: This protocol outlines methodological and practical steps as to how qualitative research can be applied to identify and develop attributes and levels for inclusion in patient preference studies aiming to inform decisions across the drug life cycle. The results of this study are intended to inform a subsequent quantitative preference survey that assesses patient trade-offs regarding lung cancer treatment options. This protocol may assist researchers, drug developers, and decision-makers in designing qualitative studies to understand which treatment aspects are most valued by patients in drug development, regulation, and reimbursement.
Keywords:
drug decision-making; drug development; focus group discussion; lung cancer; nominal group technique; patient involvement; patient preferences; patient-centered research
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