How do cancer clinicians perceive real-world data and the evidence derived therefrom? Findings from an international survey of the European Organisation for Research and Treatment of Cancer

real-world evidence, real-world data, oncology, cancer, survey, clinicians, randomized controlled trials, Europe

Real-world evidence (RWE) is increasingly being used in the development and decision-making processes for anticancer therapies, but clinician views on its use are unclear. A survey conducted between May and July 2021 involved 557 clinicians from 30 countries and 13 cancer domains. Most clinician…

Aug 1^st • 45 mins read

External control arms in oncology: current use and future directions

external controls, real-word data, Food and Drug Administration, FDA, external control arm

Considerations for using external controls in oncology clinical trials are complex and depend on their intended use. There is a review of recent research and marketing applications that describe the current usage of external control data in oncology. Incorporating external controls for prima…

Jan 9^th • 9 mins read

Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application

RWE, Biologics License, FDA, BLA, suplements

The FDA emphasizes early engagement and transparent protocols in Real-World Evidence (RWE) studies. Aligning RWE populations with pivotal trial populations is crucial, often achieved through criteria matching and propensity score methodologies. Major critiques include differences in tumor asse…

Jan 1^st • 12 mins read