Real-World Evidence in a Patient-Centric Digital Era (2022) Pdf Free Download

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Features of Real-World Evidence in a Patient-Centric Digital Era (2022) PDF free download:

 

The Food & Drug Administration (FDA) defines Real-World Data (RWD) as “the data relating to patient health status and/or the delivery of healthcare routinely collected from a variety of sources” (FDA, 2022a). Healthcare facilities routinely collect medical and patient data and electronically record them when patients use their facilities. Such recording continues even after patients leave the healthcare facility. The gathering of these data provides the healthcare community with a significant amount of useful medical and patient information. Real-world evidence (RWE) “is the clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of RWD” (FDA, 2022a). As the name suggests, RWE provides scientific and clinically relevant real-world information to improve medical care for patients globally (FDA, 2018).

Digital technologies support access to quality healthcare in a number of ways  and for separable purposes. They include electronic healthcare (“eHealth”), which covers a range of electronic technologies applied to healthcare and relates principally to the application of computers. Mobile health (“mHealth”) relates to the subset of eHealth that uses mobile technologies to share information over the radio waves. Artificial intelligence combines systems that mimic human intelligence and robust datasets to propel healthcare with new insights across early diagnosis, prevention, and treatment. Randomized controlled trials (RCTs) often do not address the complex intersection of many diseases and comorbid conditions, which are patient centric and require us to find alternate ways of getting evidence to support such need gaps.

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