Advancing the Science of Patient Input in Medical Product R&D Towards a Research Agenda: Proceedings of a Workshop—in Brief (2018) / Chapter Skim
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Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda: Proceedings of a Workshop - in Brief
Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda: Proceedings of a Workshop - in Brief
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, with consideration of downstream regulatory and post-market decision making. The objectives of the workshop were to consider the current state of the science for soliciting and incorporating patient input into medical product R&D, explore gaps in knowledge and other barriers that impede progress, and discuss a potential framework for a research agenda for addressing gaps and barriers that could help move the field forward.
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One insight was that development programs are not involving patients early enough in the translational phase of research. It is important to understand what aspects of disease burden and treatment matter most to patients and their families and how to measure them, what aspects of clinical trials can be better tailored to meet the needs and interests of potential clinical trial participants, how to better integrate PRO data or elicited patient preferences into assessments, and how best to communicate information to patients and prescribers, said Mullin.
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defines PPI as "qualitative or quantitative assessments of the relative desirability or acceptability to patients of specified alternatives or choices among outcomes or other attributes that differ among alternative health interventions." Following a breakout session, the workshop participants reconvened for a moderated plenary discussion. Identifying and Assessing Methods for Eliciting Patient Preferences Across the Medical Product Development Lifecycle Mats Hansson from Uppsala University described the PREFER10 project, an ongoing project to understand what matters to patients, how it matters, and what matters most at different decision points in the medical product lifecycle.
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"We need to step back and look at the broader landscape when we talk about patient preferences and say what are the needs and how can patient preferences and patient preference information begin to fulfill those needs," said Hauber. Considering Patient Preferences in Regulatory Decisions Kathryn O'Callaghan from FDA's CDRH highlighted a second regulatory use case for considering patient perspectives in weighing benefit and risk information, as well as two key resources FDA created to help move the field forward.
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The workshop participants again separated into breakout sessions for discussion following the presentations then reconvened for a final moderated plenary discussion. Optimizing Clinical Trial Protocols with Patient Input To develop a new framework for optimizing clinical trials, AstraZeneca ran an onsite study simulation involving 18 clinical trial participants who went through the rigors of a clinical trial from completing a mock informed consent procedure through a mock dosing visit, explained Lynn Hagger of AstraZeneca.15 After consulting with the mock trial participants, AstraZeneca made 21 changes to its clinical trial protocol, such as providing trial participants with simple background materials in lay language, better educating trial staff about the study, making the trial setting more comfortable, and creating a Web portal where trial participants could examine their results.
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Donna Cryer of the Global Liver Institute highlighted that discussions by workshop participants in her breakout session focused on the limitations associated with the use of prospective versus retrospective registries, which may not have been created specifically for research purposes. Jaye Bea Smalley of Celgene mentioned that in her breakout session, workshop participants discussed the lack of data on patient experience with a disease or a medical condition and patient input in electronic health records (EHRs)
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Exploring Methods and Approaches Individual workshop participants discussed methods and approaches that could be employed to address existing gaps and barriers in understanding patient preferences on benefit and risk. Some workshop participants considered approaches to make the collection of PPI easier and how additional resources for research could be supported.
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Some workshop participants discussed tools and techniques that could better support incorporating patient input into clinical trial design. Sharpe stated that tools designed to measure the experience of trial participants -- particularly as it affects recruitment, enrollment, attention, and trial cost and duration -- would be beneficial.
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Finally, because there is a dearth of data on how medical devices perform in real-world populations, EHRs and claims data could be sources to help identify relevant outcomes, said Rachael Fleurence of the National Evaluation System for health Technology Coordinating Center. Considering Stakeholders to Engage Some workshop participants identified relevant stakeholders that could be engaged to facilitate incorporating patient input into clinical trials.
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2018. Advancing the science of patient input in medical product R&D: Towards a research agenda: Proceedings of a workshop -- in brief.
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