Estimating the duration of ongoing prevention trials.
The authors present a method of estimating the duration of ongoing prevention trials, showing how the method was applied to the Colon Cancer Control Study, a University of Minnesota study of occult blood testing undertaken to screen for colorectal cancer in older Minnesotans. In that study, begun in 1975 and ongoing, as in several other recent large prevention trials, it was necessary, after the start of the study, to revise upward the initial estimates of study duration derived from general population experience. The underestimates arose because the planners had not adequately taken various population selection factors into account in estimating the expected number of events in the control group. In this paper, the authors outline a method for estimating control group event rates and study duration requirements (and, in some circumstances, also sample size requirements) of prevention studies, via models of disease-specific and all-cause standardized mortality ratios which adjust for various selection effects. The authors also validate the model for disease-specific standardized mortality ratios by means of independent estimates of disease incidence and case survival.
Church
T R
TR
Division of Environmental and Occupational Health, School of Public Health, University of Minnesota, Minneapolis 55414.
Ederer
F
F
Mandel
J S
JS
Watt
G D
GD
Geisser
M S
MS
D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000379:methods*; D015179:Colorectal Neoplasms / Q000453:epidemiology / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008910:Minnesota / Q000453:epidemiology; D009026:Mortality; D011315:Preventive Medicine; D012107:Research Design; D016019:Survival Analysis; D013997:Time Factors