BackgroundIn recent years there has been an increasing, partially also critical interest in understanding the potential benefits of generating real-world evidence (RWE) in medicine.ObjectivesThe 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 methodsThis article is based on a selective literature search (predominantly 2015–2017) combined with our practical experience to date in establishing European oncology RWE networks.ResultsRWE 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.ConclusionBased 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.

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Open to all European cancer centers, all cancer patients, and all cancer types, the Oncology Data Network (ODN) aims to create an extensive infrastructure of real-world cancer care information. This article describes the ODN's methodological approaches, challenges, and achievements to date.

the UK (42%). Of these, the most frequently utilized endpoints were clinical in the US (62.5%) and both clinical and humanistic (20%, respectively) in the UK. Humanistic outcomes were not mentioned in US-based contracts. 25% of US-based contracts also stipulated components of patient compliance, compared to 1 UK-based contract. Conclusions: In an environment of rising prices, VBCs are becoming a cost containment strategy. However to date, only 61 VBCs were noted in the US and UK over 2 decades, which could be driven by lack of contracts and/or transparency in reporting. The lack of contracts could be driven by the challenges of data collection and analysis, which will likely be mitigated by the development of RWE methods for VBCs. More research and transparency is needed on the structure and successes of VBCs and how RWE can improve VBCs.