<p>Harnessing Real-World Data for Regulatory Use and Applying Innovative Applications</p>

Abstract

A vast quantity of real-world data (RWD) are available to healthcare researchers. Such data come from diverse sources such as electronic health records, insurance claims and billing activity, product and disease registries, medical devices used in the home, and applications on mobile devices. The analysis of RWD produces real-world evidence (RWE), which is clinical evidence that provides information about usage and potential benefits or risks of a drug. This review defines and explains RWD, and it also details how regulatory authorities are using RWD and RWE. The main challenges in harnessing RWD include collating and analyzing numerous disparate types or categories of available information including both structured (eg, field entries) and unstructured (eg, doctor notes, discharge summaries, social media posts) data. Although the use of artificial intelligence to capture, amalgamate, standardize, and analyze RWD is still evolving, it has the potential to support the increased use of RWE to improve global health and healthcare.

New Strategies to Improve Patient Adherence to Medications for Noncommunicable Diseases During and After the COVID-19 Era Identified via a Literature Review

“…The application of AI and robotic process automation can help with the collection, collation, integration, and analysis of data from disparate sources. 67 Real-world data (RWD) and real-world evidence (RWE) are becoming increasingly important in healthcare, across a broad range of different areas including regulatory submissions for medication label expansions and discussions around pricing and the budgetary impact of medications. [67][68][69][70][71][72][73][74][75][76][77] RWD and RWE have been utilized for many decades to evaluate the effects of poor adherence (or conversely the benefits of improving adherence) with medications used to manage NCDs.…”

“…67 Real-world data (RWD) and real-world evidence (RWE) are becoming increasingly important in healthcare, across a broad range of different areas including regulatory submissions for medication label expansions and discussions around pricing and the budgetary impact of medications. [67][68][69][70][71][72][73][74][75][76][77] RWD and RWE have been utilized for many decades to evaluate the effects of poor adherence (or conversely the benefits of improving adherence) with medications used to manage NCDs. 33,[36][37][38]78 During 2020, RWD and RWE have been at the forefront of the efforts to address the healthcare challenges of the COVID-19 pandemic.…”

“… 94 However, the more involved interventions and programs were not surprisingly more costly than the simpler ones. 92 The wider availability of RWD and technology such as connected devices 67 means that there are now many more means of interacting with patients with NCDs, and potentially improving their adherence. Some of the alterations to medical practice noted above, such as telemedicine and ehealth, seem likely to stay in place long after the pandemic.…”

Association between the New COVID-19 Cases and Air Pollution with Meteorological Elements in Nine Counties of New York State

“…In recent years, RWD from routine healthcare settings, like EHR powered by statistical analysis and machine learning techniques, produces RWE [49].…”

The emerging role of real-world data in advanced breast cancer therapy: Recommendations for collaborative decision-making

“…In male patients with aBC, for whom RCTs were not feasible, RWD supported the inclusion of this subpopulation in palbociclib's label [ 28 ]. It is also crucial to involve patients in the interpretation of RWE to prioritize outcomes most meaningful to them [ 29 ] and educate stakeholders on the relative value of different outcomes evaluated in RCTs or disease management programs [ 30 ].…”