Abstract
The term "real-world evidence" (rwe) describes the analysis of data that are collected beyond the context of clinical trials. The use and application of rwe have become increasingly common and relevant, especially in oncology, because there is growing recognition that randomized controlled trials (rcts) might not be sufficiently representative of the entire patient population that is affected by cancer, and that specific clinical research questions might be best addressed by real-world data. In this brief review, our main aim is to highlight the role of rwe in informing cancer care, particularly focusing on specific examples from colorectal cancer. Our hope is to illustrate the ways in which rwe can complement rcts in improving the understanding of cancer management and how rwe can facilitate cancer treatment decisions for real-world patients encountered in routine clinical care.
Highlights
“real-world evidence” refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials[1,2]
Real-world data are derived from various sources, which can include, but are not limited to, information stored in paper or electronic medical records, pharmacy claims or physician billing databases, retrospective or prospective disease registries, patient-reported outcomes, and mobile or wearable devices[2]
Pharmaceutical partners and health care payers are both increasingly looking to rwe to inform, respectively, future study designs and funding decisions to ensure that the right drugs are made available to the right patients and that outcomes observed in rcts are reproduced in the real world[4]
Summary
“real-world evidence” (rwe) refers to evidence derived from the use and analysis of real-world data, which are data obtained outside the context of conventional randomized controlled trials (rcts)[1,2]. Pharmaceutical partners and health care payers are both increasingly looking to rwe to inform, respectively, future study designs and funding decisions to ensure that the right drugs are made available to the right patients and that outcomes observed in rcts are reproduced in the real world[4]. In this brief review article, we describe the role of rwe in informing cancer care, drawing on specific examples from the colorectal cancer (crc) space. We highlight the ways in which rwe complements rcts in improving our understanding of cancer management and some of the pitfalls that should be recognized when interpreting the results of rwe studies
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