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Emergence of Real World Evidence in Precision Medicine
Published in Shaker A. Mousa, Raj Bawa, Gerald F. Audette, The Road from Nanomedicine to Precision Medicine, 2020
In contrast, the FDA defines RWE as “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD” (emphasis in original text) [11]. The Duke-Margolis Center for Health Policy stated in a 2017 white paper prepared with FDA funding, that RWE is “evidence derived from RWD through the application of research methods” (italics added) [12]. RWE has also been described as “information that is generated in health care systems outside of a controlled trial” [13]. RWE is not merely passively collected or anecdotal data. Rather, RWE results from careful study designs for assessing treatment effects on patient outcomes [12].
Emergence of Real World Evidence in Precision Medicine
Published in Shaker A. Mousa, Raj Bawa, Gerald F. Audette, The Road from Nanomedicine to Precision Medicine, 2019
In contrast, the FDA defines RWE as “clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD” (emphasis in original text) [11]. The Duke-Margolis Center for Health Policy stated in a 2017 white paper prepared with FDA funding, that RWE is “evidence derived from RWD through the application of research methods” (italics added) [12]. RWE has also been described as “information that is generated in health care systems outside of a controlled trial” [13]. RWE is not merely passively collected or anecdotal data. Rather, RWE results from careful study designs for assessing treatment effects on patient outcomes [12].
An accelerated access pathway for innovative high-risk medical devices under the new European Union Medical Devices and health technology assessment regulations? Analysis and recommendations
Published in Expert Review of Medical Devices, 2023
Rosanna Tarricone, Helen Banks, Oriana Ciani, Werner Brouwer, Michael F Drummond, Reiner Leidl, Nicolas Martelli, Laura Sampietro-Colom, Rod S. Taylor
An implication of increased decision uncertainty in pre-market space is the expectation of the need for post-market confirmatory trials once (accelerated) conditional approval has been obtained [20,41]. As post-market evaluations are likely to be based on a larger patient population, weak or delayed signals of harm may be detected more easily and if significant, may lead to the withdrawal of the technology [58,63]. In those cases where RCTs are feasible, post-market trials could address larger patient populations. In other cases, real world data and real world evidence are indicated for post-marketing surveillance, but are also of potential use in clinical study designs and adjustments in earlier phases [64,65]. Registry studies can be particularly important for high-risk implantable MDs, given the expected impact of ancillary technologies, surgical technique and experience development over time, as well as any design modifications or failures related to design that may develop as the device is used on a larger scale in real world settings [3,65,66]. An important requisite is the willingness and ability to remove a product from the market should its early promise in terms of clinical efficacy and safety, not be confirmed by evidence generated during the post-market phase. However, unequivocal requirements for post-market data collection are not common [20,26,67]. Therefore, the use of registry results in regulatory assessment may benefit from implementation guidance, e.g. on data collection and quality assurance, registry governance, and planning of benefit-risk assessments [68].
The current status of breakthrough devices designation in the United States and innovative medical devices designation in Korea for digital health software
Published in Expert Review of Medical Devices, 2022
Jae Hyun Woo, Eun Cheol Kim, Sung Min Kim
AI -based SaMD can clearly identify clinical improvements using big data in the clinical environment. DTx, which is being developed by the group, is also expected to increase the clinical outcomes. The fundamental implications for resolving the limitations of the initial experience of these programs are the application of an economic premium policy [89–91] and stricter risk-benefit assessment [91–93] for rare incurable diseases or medical technologies for which no clear alternative exists and the mandatory requirements for disclosure among currently designated items. Systematic information sharing and dissemination are necessary for the total product life cycle management to create real-world data(RWD) and real-world evidence(RWE) of approved items and approaches to ensure clinical safety and efficacy [3,94–98]. This approach is thought to contribute to better and innovative medical technology by providing the best value to clinical sites and patients easily and rapidly.