Version 1
: Received: 7 July 2022 / Approved: 8 July 2022 / Online: 8 July 2022 (11:09:58 CEST)
How to cite:
Schad, F.; Thronicke, A. Real World Evidence – Current Developments and Perspectives. Preprints2022, 2022070141. https://doi.org/10.20944/preprints202207.0141.v1
Schad, F.; Thronicke, A. Real World Evidence – Current Developments and Perspectives. Preprints 2022, 2022070141. https://doi.org/10.20944/preprints202207.0141.v1
Schad, F.; Thronicke, A. Real World Evidence – Current Developments and Perspectives. Preprints2022, 2022070141. https://doi.org/10.20944/preprints202207.0141.v1
APA Style
Schad, F., & Thronicke, A. (2022). Real World Evidence – Current Developments and Perspectives. Preprints. https://doi.org/10.20944/preprints202207.0141.v1
Chicago/Turabian Style
Schad, F. and Anja Thronicke. 2022 "Real World Evidence – Current Developments and Perspectives" Preprints. https://doi.org/10.20944/preprints202207.0141.v1
Abstract
Real-world evidence (RWE) is increasingly involved in the early benefit assessment of medicinal drugs. It is expected that RWE will help to speed up approval processes comparable to RWE developments in vaccine research during the COVID-19 pandemic. Definitions of RWE are diverse marking the highly fluid status in this field. So far, RWE comprises information produced from data routinely collected on patient’s health status and/or delivery of health care from various sources other than traditional clinical trials. These sources can include electronic health records, claims, patient-generated data including in home-use settings, data from mobile devices as well as patient, product and disease registries. The aim of the present update was to review the current RWE developments and guidelines mainly in the U.S., the UK, Europe and Germany field during the last decade. RWE has already been included in various approval procedures of regulatory authorities reflecting its actual acceptance and growing importance in evaluating and accelerating new therapies. However, since the RWE research is still in a transition process and since a number of gaps in this field have been explored, more guidance and a consented definition are necessary to increase the implementation of real-world data.
Keywords
review; real -world evidence; real -world data; randomized controlled trials; registry; digital health technology; early drug approval
Subject
Medicine and Pharmacology, Oncology and Oncogenics
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
