Methods and approaches of systematically obtaining, analyzing, and using information that capture patients’ experiences, perspectives, needs, and priorities in support of the development and evaluation of medical products.
- Patient-Focused Drug Development Glossary, Food and Drug Administration’s (FDA): https://www.fda.gov/drugs/development-approval-process-drugs/patient-focused-drug-development-glossary
To go in depth
Advancing the science of patient input
This paper considers the current state of the science for soliciting and incorporating patient input into medical product research and development.
- Advancing the Science of Patient Input in Medical Product R&D, Towards a Research Agenda: Proceedings of a Workshop National Academies of Sciences, Engineering, and Medicine: National Academies Press (US); 2018: https://nap.nationalacademies.org/catalog/25325/advancing-the-science-of-patient-input-in-medical-product-rd
Science of patient input and drug development
This position paper from EUCOPE is a systematic collection and incorporation of patient input/patient experience data throughout the drug development lifecycle.
- Patients’ centricity and science of patient input, EUCOPE (European Confederation of Pharmaceutical Entrepreneurs) Position paper, 2021: https://www.eucope.org/wp-content/uploads/2022/05/eucope-position-paper-science-of-patient-input-2021.pdf
Understanding the value of patient input
This article highlights current initiatives on advancing the science of patient input in a regulatory setting, in particular, patient preference information.
- Tegenge MA et al. Advancing the science of patient input throughout the regulatory decision‐making process. 2017: https://pmc.ncbi.nlm.nih.gov/articles/PMC6508573/
Opportunities and challenges of patient input
This review aims to understand the potential roles, reasons for using patient preference (PP) and the expectations, concerns and requirements associated with PP in industry processes.
- Janssens R et al. Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review BMC Medical Informatics and Decision Making 2019; 19, 189: https://pmc.ncbi.nlm.nih.gov/articles/PMC6778383/pdf/12911_2019_Article_875.pdf
