Real-world evidence research based on big data: Motivation-challenges-success factors.

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.