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Increasing power in screening trials by testing control-arm specimens: application to multicancer detection screening
Hormuzd A Katki1, Philip C Prorok2, Philip E Castle1,2
1Division of Cancer Epidemiology and Genetics, Department of Health and Human Services, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Journal of the National Cancer Institute
|April 11, 2024
Summary
The intended effect (IE) analysis, using control-arm specimens, significantly boosts cancer screening trial power. This approach can reduce sample sizes or accelerate trials, especially for multicancer detection (MCD) tests.
Area of Science:
- Oncology
- Biostatistics
- Clinical Trials
Background:
- Cancer screening trials traditionally require large sample sizes and long durations to show mortality reduction.
- The
Purpose of the Study:
- To evaluate the
Main Methods:
- Simulated hypothetical multicancer detection (MCD) screening trials.
- Compared the standard analysis with the
Main Results:
- The IE analysis demonstrated substantial power gains across three existing trials (NLST, MINN-FOBT-A, PLCO-CRC).
- Potential sample size reductions ranged from 26% to 59% for 90% power.
- For large MCD trials, the IE analysis could reduce required subjects per arm from 100,000 to 37,500-50,000.
Conclusions:
- Testing stored control-arm specimens via the IE analysis can significantly enhance statistical power in cancer screening trials.
- This method offers a viable strategy to reduce sample size requirements or accelerate trial timelines.
- The IE analysis is particularly advantageous for multicancer detection (MCD) tests, maximizing power gains.
