Real-world evidence research based on big data View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-11

AUTHORS

Benedikt E. Maissenhaelter, Ashley L. Woolmore, Peter M. Schlag

ABSTRACT

Background: In recent years there has been an increasing, partially also critical interest in understanding the potential benefits of generating real-world evidence (RWE) in medicine. Objectives: The benefits and limitations of RWE in the context of randomized controlled trials (RCTs) are described along with a view on how they may complement each other as partners in the generation of evidence for clinical oncology. Moreover, challenges and success factors in building an effective RWE network of cooperating cancer centers are analyzed and discussed. Material and methods: This article is based on a selective literature search (predominantly 2015-2017) combined with our practical experience to date in establishing European oncology RWE networks. Results: RWE studies can be highly valuable and complementary to RCTs due to their high external validity. If cancer centers successfully address the various challenges in the establishment of an effective RWE study network and in the consequent execution of studies, they may efficiently generate high-quality research findings on treatment effectiveness and safety. Concerns pertaining to data privacy are of utmost importance and discussed accordingly. Securing data completeness, accuracy, and a common data structure on routinely collected disease and treatment-related data of patients with cancer is a challenging task that requires high engagement of all participants in the process. Conclusion: Based on the discussed prerequisites, the analysis of comprehensive and complex real-world data in the context of a RWE study network represents an important and promising complementary partner to RCTs. This enables research into the general quality of cancer care and can permit comparative effectiveness studies across partner centers. Moreover, it will provide insights into a broader optimization of cancer care, refined therapeutic strategies for patient subgroups as well as avenues for further research in oncology. More... »

PAGES

91-98

Journal

TITLE

Der Onkologe

ISSUE

Suppl 2

VOLUME

24

Author Affiliations

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00761-018-0358-3

DOI

http://dx.doi.org/10.1007/s00761-018-0358-3

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1104463973

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30464373


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