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editorial

. 2020 Jul 6;55(1):90–96. doi: 10.1007/s43441-020-00193-5

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© The Author(s) 2020

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

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Figure 2. — A Framework Proposing Several Pathways to Integrating RWE in the RCT Setting Based on the Clinical Relevance and Real-World Availability of Trial Endpoints. Trial endpoints that are relevant to routine practices, show a clinical benefit, and available in the real world represent an alignment with real-world study endpoints, and these RCTs could benefit from RWE supplementation or contextualisation. However, clinical trial endpoints that are not available in the real world or that do not measure direct clinical outcomes, or both, represent a misalignment with RWE and can benefit from hybrid methodologies or building real-world infrastructure