Real-World Evidence—Current Developments and Perspectives

Friedemann Schad () and Anja Thronicke
Additional contact information
Friedemann Schad: Interdisciplinary Oncology and Palliative Care, Hospital Gemeinschaftskrankenhaus Havelhöhe, 14089 Berlin, Germany
Anja Thronicke: Research Institute Havelhöhe, Hospital Havelhöhe, 14089 Berlin, Germany

IJERPH, 2022, vol. 19, issue 16, 1-11

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 current RWE developments and guidelines, mainly in the U.S. and Europe over 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 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 (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
References: View complete reference list from CitEc
Citations: View citations in EconPapers (1)

Downloads: (external link)
https://www.mdpi.com/1660-4601/19/16/10159/pdf (application/pdf)
https://www.mdpi.com/1660-4601/19/16/10159/ (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:gam:jijerp:v:19:y:2022:i:16:p:10159-:d:889743

Access Statistics for this article

IJERPH is currently edited by Ms. Jenna Liu

More articles in IJERPH from MDPI
Bibliographic data for series maintained by MDPI Indexing Manager ().