Approaches and data needed for real-world evaluation of multicancer early detection tests.

Abstract

e15069 Background: The MCED Consortium is a group of volunteers, advisors, and companies from the US and the UK spanning a wide range of expertise in biomarker evaluation and implementation, with a special focus on clinical practice, health equity, and communication. The development of Multi Cancer Early Detection (MCED) markers may herald a new approach to screening and detection of multiple cancers at one time via various biological assays. Methods: The Consortium is developing recommendations for the evaluation of test utility, appropriate population targets for screening or early detection, downstream actions in health systems, issues of health equity, and communication challenges related to this new, potentially revolutionary generation of tests. While randomized controlled trials with cancer-specific endpoints have been the gold standard for the evaluation of cancer screening tests for decades, and have successfully shown effectiveness of breast, colorectal, cervical and lung cancer screening, there are compelling reasons not to rely entirely on those approaches to guide the evaluation and clinical use of MCEDs. Results: A large number of MCED products are likely to reach the market well before trials with mortality endpoints can be completed. The release of tests in clinical practice in the US via the laboratory-developed-test pathway means data could be available many years before data is available from trials. The MCED Consortium proposes approaches for the structure, systematic collection of real-world data that will complement such trials. This includes adopting shared definitions of RWD & RWE, definition of core data elements to be collected from all patients undergoing MCED testing, and the need for collaboration strategies across test developers, health systems, payers, clinicians, and others. Conclusions: We will present a framework for learning from clinical experience through data collection that will move MCEDs forward in the context of sensible clinical practice.