Planning clinical trials to evaluate early detection programmes

SUMMARY 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.

[1]  Philip C. Prorok,et al.  The theory of periodic screening I: Lead time and proportion detected , 1976, Advances in Applied Probability.

[2]  S. Wall,et al.  Breast cancer screening with mammography: overview of Swedish randomised trials , 1993, The Lancet.

[3]  L. Tabár,et al.  REDUCTION IN MORTALITY FROM BREAST CANCER AFTER MASS SCREENING WITH MAMMOGRAPHY Randomised Trial from the Breast Cancer Screening Working Group of the Swedish National Board of Health and Welfare , 1985, The Lancet.

[4]  S D Walter,et al.  Estimation of the duration of a pre-clinical disease state using screening data. , 1983, American journal of epidemiology.

[5]  D. Eddy.  A Mathematical Model for Timing Repeated Medical Tests , 1983, Medical decision making : an international journal of the Society for Medical Decision Making.

[6]  G. W. Snedecor.  Statistical Methods , 1964 .

[7]  A. K. Shahani,et al.  Towards models of screening for early detection of disease , 1977, Advances in Applied Probability.

[8]  T. Landberg,et al.  Mammographic screening and mortality from breast cancer: the Malmö mammographic screening trial. , 1988, BMJ.

[9]  P C Prorok,et al.  Screening for the early detection of cancer. , 1986, Cancer investigation.

[10]  R. Gelman,et al.  Mammography in symptomatic and asymptomatic patients. , 1989, Hematology/oncology clinics of North America.

[11]  A. Huggins,et al.  Edinburgh trial of screening for breast cancer: mortality at seven years , 1990, The Lancet.

[12]  P. Leppard,et al.  A review of the technical features of breast cancer screening illustrated by a specific model using South Australian cancer registry data , 1995, Statistical methods in medical research.

[13]  M. Shwartz,et al.  An analysis of the benefits of serial screening for breast cancer based upon a mathematical model of the disease , 1978, Cancer.

[14]  A. Miller,et al.  Canadian National Breast Screening Study. , 1990, AJR. American journal of roentgenology.

[15]  S. Baker,et al.  Evaluating Screening for the Early Detection and Treatment of Cancer without Using a Randomized Control Group , 1990 .

[16]  Marvin Zelen,et al.  On the theory of screening for chronic diseases , 1969 .

[17]  J D Habbema,et al.  Modelling issues in cancer screening , 1995, Statistical methods in medical research.

[18]  Marvin Zelen,et al.  Optimal scheduling of examinations for the early detection of disease , 1993 .

[19]  S. Shapiro,et al.  Ten- to fourteen-year effect of screening on breast cancer mortality. , 1982, Journal of the National Cancer Institute.

[20]  A. Miller,et al.  Canadian National Breast Screening Study: 1. Breast cancer detection and death rates among women aged 40 to 49 years. , 1992, CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne.

[21]  S Shapiro,et al.  Selection, follow-up, and analysis in the Health Insurance Plan Study: a randomized trial with breast cancer screening. , 1985, National Cancer Institute monograph.

[22]  Philip C. Prorok,et al.  The theory of periodic screening II: doubly bounded recurrence times and mean lead time and detection probability estimation , 1976, Advances in Applied Probability.

[23]  P. Prorok,et al.  Design and analysis of cancer screening trials , 1995, Statistical methods in medical research.

[24]  S Shapiro,et al.  Report of the International Workshop on Screening for Breast Cancer. , 1993, Journal of the National Cancer Institute.

[25]  T. Louis,et al.  Screening for the early detection of cancer- II. The impact of screening on the natural history of the disease , 1978 .