On November 29, 2023, FDA is holding ^held an all-day panel on how the FDA should plan for trials and evaluations of MCED, multi cancer early detection.
See original blog about the FDA workshop, by me, here.
- Update November 30 - I've put several different AI summaries of the 6-hour meeting in a Google doc, here.
- This includes a 10-page bullet point summary by Otter.AI, my transcription program.
- Also short summaries by Claude.AI and Chat GPT4. (And then, having got the 2 summaries, I asked them to compare the two summaries, too.)
- See an excellent pre meeting article by Hyman Phelps here.
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FDA has posted the agenda 9-5, the key questions, and an executive summary of 10 pages.
Find them all at the FDA, here, as "Event Materials," as well as the FDA's link to the streaming video for November 29.
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I've posted a Claude.ai summary of the ten-page executive summary written by FDA.
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The FDA is convening an advisory panel to get input on regulatory considerations for multi-cancer early detection (MCED) tests. These blood-based tests aim to screen for multiple cancers simultaneously in asymptomatic individuals. Currently no MCED tests have FDA authorization.
The panel will provide recommendations on study design to demonstrate clinical validity of MCED tests. This includes determining appropriate methods to confirm cancer status, diagnostic workup following positive results, and follow-up for negatives. The panel will also discuss use of tissue-of-origin assays to help localize tumors after initial MCED positive, as well as benefit-risk considerations.
Key questions for the panel include [for original FDA text see FDA link above]:
- Should MCED tests be evaluated by cancer type or in aggregate? What minimum sensitivity per cancer?
- How to evaluate MCED versus existing single cancer screening tests? Risk of patients foregoing current methods?
- Definition of "early detection"? Supportive data needed?
- Acceptable false positive rates? Should specificity be fixed to support low false positives?
- Harms of false negatives/positives? Diagnostic odyssey? Overdiagnosis/overtreatment?
- Use of stage shift as surrogate endpoint to show benefit?
- Role of real-world evidence for expanding cancer claims, validating rare cancers, demonstrating stage shift?
The panel's discussion and recommendations will inform the FDA's thinking on evaluation of safety and effectiveness for future MCED test marketing submissions.
