A Framework to Evaluate the Clinical Utility of Multicancer Early Detection (MCED) Technologies: Balancing the Utilization of Intermediate and Long-term Data

The Multicancer Early Detection (MCED) Consortium releases a clinical utility framework to assist decision-makers in making judgments about the benefits and risks of MCED technologies.

WASHINGTON, Sept. 28, 2023 /PRNewswire/ -- Cancer screening tests are used to help find cancer before a person has any symptoms, when it may be easier to treat. Multicancer Early Detection (MCED) technologies are emerging as a promising screening tool to not only detect cancer early but also detect cancers that do not currently have an established screening test. MCEDs are a new technology, and long-term results from randomized clinical trials, the standard for evaluating test efficacy and positive patient outcomes, are not yet available. While MCEDs hold great potential to decrease the mortality rates of cancers, definitive clinical evidence about their benefits and risks will not be available for several years.

The Multicancer Early Detection Consortium Clinical Utility Workgroup has released a paper, Evaluating the Clinical Utility of Multi-Cancer Early Detection (MCED) Tests: Envisioning A Path Forward, to inform providers, guideline developers, regulators, payers, and other decision-makers who will need to make judgments about the benefits and risks of MCED testing in the context of substantial uncertainty.

"As more MCEDs are developed and become available, holding the promise of detecting a variety of cancers earlier, especially for those without available screening, there is a need for decision-makers to understand the range of study designs and data sources that will contribute to our understanding of the risks and benefits of these tests." - Sean Tunis, MCED Consortium Clinical Utility Workgroup Chair 

The paper provides an overview of the limitations of currently available cancer screening tests, the promise of MCEDs for cancers without established screening tests, the current state of MCED test development, the evolving evidence landscape for the use of MCEDs in cancer screening, and the types of clinical studies that are needed to support further development of these tests. It previews key methodologic strategies the Consortium believes should be adopted to build the evidence about these tests over time. As part of building a strong evidence base, the paper also calls on developers and researchers to include diverse populations in their studies so that all can benefit from these potentially valuable technologies without increased health care inequities. Finally, the paper helps to set expectations for future studies to inform clinical and policy decisions and outlines a path for coordinated efforts in evidence generation.

"Cooperation and collaboration among a variety of stakeholders, as represented in the MCED Consortium, is needed for successful near- and intermediate-term evaluation of MCED screening. The Consortium looks to collaborate with others working in this area, like the US FDA (Food and Drug Administration) and BLOODPAC. Additionally, there is an urgent need to align, collect, and analyze 'real-world data' from health systems, employers, and other organizations that offer MCED testing." - Larry Kessler, MCED Consortium Deputy Chair

The paper was developed by the MCED Consortium's Clinical Utility Workgroup, which is comprised of experts representing academic researchers with expertise in cancer screening, regulatory experts, payer organizations, diagnostics companies, MCED developers, and others with a shared interest in assuring high-quality evidence is accessible to decision-makers as quickly as possible.

For more information about the Consortium, visit our website.

About the Multicancer Early Detection (MCED) Consortium
Multicancer Early Detection (MCED) is a set of emerging technologies that could allow clinicians to screen and detect multiple cancers at early stages. The MCED Consortium has brought together stakeholders from across the healthcare continuum to evaluate their benefits and risks, to develop guidance for their [potential] introduction into clinical care, including equitable access and use, and to accelerate education on how they may improve patient outcomes and survival. To learn more about the Consortium, please visit our website.

About Healthsperien, LLC
Healthsperien, LLC., is a nationally recognized health care policy consulting firm focused on federal and state regulatory and legislative policy analysis, advocacy, and implementation issues. Their mission is to accelerate responsible and sustainable health care system innovation and transformation to improve health outcomes for all – especially the most vulnerable. www.healthsperien.com

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