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Biometrika 1997 84(4):817-829; doi:10.1093/biomet/84.4.817
© 1997 by Biometrika Trust
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Planning clinical trials to evaluate early detection programmes

PING HU and MARVIN ZELEN

Division of Biostatistics, Dana Farber Cancer Institute 44 Binney Street, Boston, Massachusetts 02115, U.S.A. e-mail: phu{at}jimmy.harvard.edu zelen{at}jimmy.harvard.edu

The lack of statistical theory for the planning of early detection trials has resulted in current trials being sub-optimal. We develop probability models that address three characteristics of early detection trials: (i) the optimal time of analysis and length of follow-up, (ii) the optimal spacing between examinations, and (iii) the planning of trials where the numbers of examinations versus sample size are balanced for fixed costs. The optimisation criterion is to maximise the power of the statistical test for comparing mortality. Application is made to breast cancer early detection trials.

Key Words: Breast cancer • Clinical trial • Design of experiments • Early detection • Screening


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