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- W2011025708 abstract "A procedure has been developed, and tables presented, for estimating sample size requirements in the planning stage of a clinical trial where patients are to enter the study in cohorts rather than simultaneously. It is assumed that patient entry will be for T-yr, with one additional year of follow-up, before results are to be reported. The determination of required accrual rates is governed by the desire to demonstrate a statistically significant increase in the T-yr survival (or, more generally, incidence) rate of an experimental group over that experienced by a control group. The method also permits inclusion of anticipated loss to follow-up rates. It is stressed that the procedure can be of value in terms of providing guidelines for assessing the adequacy of sample accrual. Such projections may aid the investigator in planning for the optimum use of case material, facilities and personnel as well as in monitoring the trial as it progresses. It is to be noted that after the study is actually terminated analyses of the data based on total survival experience, rather than only the comparison of T-yr survival rates, should be considered. The use of the tables has been illustrated on two studies involving chronic disease. One deals with the planning of a clinical trial in patients with Stage I or II Hodgkin's disease; the other involves the planning of a currently ongoing five-year study designed to evaluate a new technique in the surgical treatment of colo-rectal cancer." @default.
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- W2011025708 title "Sample sizes for clinical trials designed for patient accrual by cohorts" @default.
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- W2011025708 doi "https://doi.org/10.1016/0021-9681(72)90003-3" @default.
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