Examining the Impact of Real-World Evidence on Medical Product Development I. Incentives: Proceedings of a Workshop—in Brief (2018) / Chapter Skim
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Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives: Proceedings of a Workshop - in Brief
Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives: Proceedings of a Workshop - in Brief
Pages 1-10
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Gregory Simon of the Kaiser Permanente (KP) Washington Health Research Institute told the workshop participants that establishing a common language will be key to understanding and changing the traditional paradigm of evidence generation, and he emphasized that real-world data (RWD)
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Sherman said that payers could encourage FDA to collect postmarketing data for cases in which there are limited data on a given treatment -- a practice the agency often already engages in and one that creates RWD that can be used to better study patient outcomes. An Integrated Health Care System Perspective Michael Horberg of KP described the perspective of a health care delivery system on RWE, focusing on KP's integrated care model.
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A Patient Perspective Sharon Terry of Genetic Alliance reminded participants that the term "patient" implies a power imbalance between the practitioner and the individual seeking treatment, saying that many health professionals would approach decisions differently if they put their personal health before business or industry preferences. Patients, she said, are concerned about their own health, and groups of them have created disease- or condition-centric communities to represent their interests and generate data to inform health care decisions.
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Kane said that these studies required far more investment in data processing and error management than traditional clinical studies. This was due to variability in the data as they were collected as well as the scale and complexity of the data linkages required to determine patient outcomes.
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However, Platt said that this model is expensive to maintain and is only successful if the data partners continue to find it useful. Applying Lessons Learned from Device Registries to Other Treatment Types Rachael Fleurence of the National Evaluation System for Health Technology (NEST)
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In device development and use, RWD could be used to generate robust postmarket data to support earlier premarket decisions, help researchers recognize and assess safety problems sooner, help medical professionals determine better ways of using a device, and help researchers design rigorous studies that will be able to reliably detect safety and efficacy outcomes. NEST was established, Fleurence said, to promote these applications and "serve as a catalyst to support timely and reliable development of high-quality RWE." GETTING UNSTUCK: ALIGNING INCENTIVES In Session III, Getting Unstuck: Aligning Incentives, workshop participants discussed incentives for maintaining the current data generation processes and potential barriers to the use of new methods of evidence generation.
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Wilson argued that the solution is to defragment the patient view by sharing data responsibly and creating value by linking data from disparate parts of the health system as well as patient-provided information. He said that institutions that collect and share these data should adhere to core principles, including protecting patient privacy and security, using data only for those purposes for which they are fit, and actively creating a learning health system.
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A Data Aggregator Perspective Patrick Ryan of Janssen Research and Development discussed some of the methods being developed at Observational Health Data Sciences and Informatics (OHDSI)
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She also discussed innovative trial designs, such as master protocols or platform trials, as promising ways to incorporate RWD. To carry out innovative trial designs will require additional work in standardization, verification, and training as well as potentially different strategies for development or funding structures and academic rewards, but these designs offer tangible opportunities to more easily adopt new practices in the clinic; to answer multiple questions simultaneously, including comparative effectiveness; and to maintain the focus on patients.
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The statements made are those of the rapporteurs or individual workshop participants and do not necessarily represent the views of all workshop participants; the planning committee; or the National Academies of Sciences, Engineering, and Medicine. REVIEWERS: To ensure that it meets institutional standards for quality and objectivity, this Proceedings of a Workshop -- in Brief was reviewed by John Doyle, QuintilesIMS; and Rachael Fleurence, National Evaluation System for Health Technology (NEST)
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