Trial Design Based on Surrogate End Points--Application to Comparison of Different Breast Screening Frequencies

N. E. Day; Stephen W. Duffy

doi:10.2307/2983468

January 1, 1996Journal of the Royal Statistical Society Series A (Statistics in Society)

Trial Design Based on Surrogate End Points--Application to Comparison of Different Breast Screening Frequencies

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Key Points

To establish a statistical trial design framework using surrogate end points to evaluate and compare different breast cancer screening frequencies efficiently.
Modeled surrogate markers, including tumor size and nodal involvement at diagnosis, to substitute for long-term breast cancer mortality endpoints.
Calculated sample size specifications, statistical power, and follow-up duration required to detect differences between alternative screening intervals (such as annual versus triennial regimes).
Demonstrated that intermediate tumor characteristics provide valid surrogates that substantially decrease study duration and patient enrollment targets compared to conventional mortality trials.
Showed that statistical precision and trial validity depend critically on the quantitative relationship between intermediate prognostic traits at detection and ultimate disease fatality.

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Implication

Statistical modeling study reveals surrogate end points optimize trial design for breast screening frequencies, suggesting faster evaluation of screening intervals.

Abstract

N. E. Day, S. W. Duffy, Trial Design Based on Surrogate End Points--Application to Comparison of Different Breast Screening Frequencies, Journal of the Royal Statistical Society. Series A (Statistics in Society), Vol. 159, No. 1 (1996), pp. 49-60

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Day et al. (1996) studied this question.

synapsesocial.com/papers/6a92f79e7638626b808c9a99 https://doi.org/10.2307/2983468

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Trial Design Based on Surrogate End Points--Application to Comparison of Different Breast Screening Frequencies

Key Points

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Trial Design Based on Surrogate End Points--Application to Comparison of Different Breast Screening Frequencies

Key Points

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Implication

Abstract

Discussion

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