Do We Still Need Randomized Controlled Trials to Support Use of New Methods of Breast Cancer Screening?

Randomized controlled trials (RCTs) have confirmed the mortality benefits of screening mammography and are the gold standard for evaluating new diagnostic tests and medical interventions. Reliable and rigorous execution of RCTs can be complex and require high levels of funding and prolonged time from technology implementation to trial completion. Breast radiology and artificial intelligence technologies are being developed and are receiving regulatory approval faster than RCTs may be effectively conducted. Regulatory approval can lead to societal recommendations, legislation, clinical availability, purchasing, and patient care, even in the absence of reliable evidence indicating increased efficacy. Marketing and patient demand and physician perceptions influence technology use. There is a wide chasm between using data provided by RCTs and site-specific care decisions. Can we find a middle ground? What types of data can influence guidelines in the absence of rigorous clinical trials? This article explores the benefits and drawbacks of RCTs and describes professional initiatives, such as widespread use of method of detection, that could allow the breast imaging community to more quickly evaluate and integrate new technologies in a reasoned and evidence-based fashion.