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Real-world evidence research based on big data: Motivation-challenges-success factors.
Benedikt E Maissenhaelter1, Ashley L Woolmore2, Peter M Schlag3
1IQVIA (formerly Quintiles & IMS Health), Landshuter Allee 10, 80637 Munich, Germany.
Der Onkologe : Organ Der Deutschen Krebsgesellschaft E.V
|November 23, 2018
Summary
Real-world evidence (RWE) studies offer valuable insights complementing randomized controlled trials (RCTs) in oncology. Establishing robust RWE networks is crucial for generating high-quality data on treatment effectiveness and safety.
Area of Science:
- Oncology
- Health Services Research
- Biostatistics
Background:
- Growing interest in the benefits and critical evaluation of real-world evidence (RWE) in medicine.
- RWE is increasingly recognized for its potential to supplement traditional research methods.
Purpose of the Study:
- To describe the benefits and limitations of RWE in relation to randomized controlled trials (RCTs).
- To explore how RWE and RCTs can complement each other in generating evidence for clinical oncology.
- To analyze challenges and success factors in establishing European oncology RWE networks.
Main Methods:
- Selective literature search (2015-2017).
- Incorporation of practical experience in establishing European oncology RWE networks.
Main Results:
- RWE studies possess high external validity, making them valuable complements to RCTs.
- Successful RWE networks can yield high-quality findings on treatment effectiveness and safety.
- Data privacy, completeness, accuracy, and common data structures are critical challenges requiring participant engagement.
Conclusions:
- RWE study networks are a promising complementary partner to RCTs for analyzing complex real-world data.
- RWE facilitates research on cancer care quality, comparative effectiveness, and therapeutic strategy optimization.
- RWE networks provide insights for broader cancer care optimization and future research avenues.
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