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Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making
- Source :
- Journal of Multidisciplinary Healthcare
- Publication Year :
- 2018
- Publisher :
- Informa UK Limited, 2018.
-
Abstract
- Vaibhav B Katkade, Kafi N Sanders, Kelly H Zou Pfizer Inc, New York, NY, USA Abstract: Evidence from medication use in the real world setting can help to extrapolate and/or augment data obtained in randomized controlled trials and establishes a broad picture of a medication’s place in everyday clinical practice. By supplementing and complementing safety and efficacy data obtained in a narrowly defined (and often optimized) patient population in the clinical trial setting, real world evidence (RWE) may provide stakeholders with valuable information about the safety and effectiveness of a medication in large, heterogeneous populations. RWE is emerging as a credible information source; however, there is scope for enhancements to real world data (RWD) sources by understanding their complexities and applying the most appropriate analytical tools in order to extract relevant information. In addition to providing information for clinicians, RWE has the potential to meet the burden of evidence for regulatory considerations and may be used in approval of new indications for medications. Further understanding of RWD collection and analysis is needed if RWE is to achieve its full potential. Keywords: electronic health records, evidence-based medicine, real world data, real world evidence, randomized controlled trial
- Subjects :
- Computer science
real world evidence
Real world evidence
law.invention
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Health care
030212 general & internal medicine
General Nursing
Scope (project management)
business.industry
Journal of Multidisciplinary Healthcare
General Medicine
Evidence-based medicine
Clinical trial
real world data
electronic health records
Risk analysis (engineering)
030220 oncology & carcinogenesis
randomized controlled trial
Information source
evidence-based medicine
business
Real world data
Perspectives
Subjects
Details
- ISSN :
- 11782390
- Volume :
- 11
- Database :
- OpenAIRE
- Journal :
- Journal of Multidisciplinary Healthcare
- Accession number :
- edsair.doi.dedup.....4c90dd6c474a420f7bc30b95ff8426e3