How Early Detection & Diagnostic Products Will Shape the Future of Healthcare

New early detection and diagnostic products are greatly needed, as we must intersect with patients earlier in their disease progression to improve outcomes. However, the use of currently available screening tools indicates large gaps in utilization, payor coverage, and patient access, especially in oncology. What can we learn from the real-world use of current early detection and diagnostic products, and how can we apply those insights to optimize clinical trial design?

“How Early Detection & Diagnostic Products Will Shape the Future of Healthcare,” the third roundtable in the Elligo Elite Learning Series, explores the barriers between healthcare, patients, and new early detection and diagnostic methods and how improving the design of clinical trials in this therapeutic area will lead to a more patient-centered trial experience and faster adoption of life-improving and lifesaving tools. Featuring Elligo Health Research® experts, the discussion unfolds in four parts: the current state of cancer diagnostics, common barriers to cancer screenings and their implications for research, designing early detection and diagnostic trials to meet patient needs and decrease health disparities, and operational tips for diagnostic clinical trials.

The Current State of Cancer Diagnostics

The first contemporary example of using a blood test to detect cancer wasn’t that long ago, nor was it on purpose. This serendipitous discovery became the basis for the development of clinical applications for cancer detection, but how has cancer diagnostics evolved since then?

Faith Holmes, M.D., Medical Director, Senior Vice President of Medical Affairs, Elligo, describes the current state of cancer diagnostics including the three main ways cancer is detected and why we desperately need a better way of diagnosing cancer earlier.

Common Barriers to Cancer Screenings and Their Implications for Research

In this section of the roundtable, Faith details common barriers to cancer screenings, such as discrepancies between updated recommendations and real-world standards of care, the lack of awareness around the importance of screening, social determinants of health, and concerns surrounding overdiagnosis. She also discusses the implications screening barriers have for clinical research, focusing on the concept that the goal of a new diagnostic shouldn’t be just to diagnose but to reduce deaths through earlier detection, and how this concept should inform clinical trial design.

Designing Early Detection and Diagnostic Trials to Meet Patient Needs and Decrease Health Disparities

How can we increase access to new diagnostics for traditionally underserved or underrepresented patient populations? Faith digs into this question, first by outlining the main differences between FDA approval and Medicare coverage determination and how these differences impact health disparities when it comes to early detection, and then by detailing various payor considerations and how they impact trials and trial design. Lastly, she gives actionable ideas for designing trials to better meet real-world early detection needs and decrease health disparities for minority groups.

Operational Tips for Diagnostic Clinical Trials

In the final portion of the webinar, Dawn Sauro, Executive Vice President, Research Strategy, Elligo, provides tips for enhancing diagnostic clinical trial operations, like potential engagement points for optimizing patient enrollment, getting medical records release forms early, and more. She also uses a case study as an example of her tips in action, giving even more detail on how to best design and run diagnostic research.

Explore the Elligo Elite Learning Series

For further insights into the connections between real-world diagnostics and clinical research and how we can improve both to better serve patients, watch the recording of the third Elligo Elite Learning Series roundtable.

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