Sample size calculations for comparative clinical trials with over-dispersed Poisson process data

被引：23

作者：

Matsui, S ^{[1
]}

机构：

[1] Kyoto Univ, Sch Publ Hlth, Dept Pharmacoepidemiol, Sakyo Ku, Kyoto 6068501, Japan

来源：

STATISTICS IN MEDICINE | 2005年 / 24卷 / 09期

关键词：

recurrent events; over-dispersed Poisson process; clinical trials; sample size calculation;

D O I：

10.1002/sim.2011

中图分类号：

Q [生物科学];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

This paper develops a new formula for sample size Calculations for comparative clinical trials with Poisson or over-dispersed Poisson process data. The criteria for sample size calculations is developed on the basis of asymptotic approximations for a two-sample non-parametric test to compare the empirical event rate function between treatment groups. This formula can accommodate time heterogeneity, interpatient heterogeneity in event rate, and also, time-varying treatment effects. An application of the formula to a trial for chronic granulomatous disease is provided. Copyright (c) 2004 John Wiley & Sons, Ltd.

引用

页码：1339 / 1356

页数：18

共 33 条

[1]

ABULIBDEH H, 1991, BIOMETRICS, V47, P1371

[2]

Anderson P. K., 1993, STAT METHODS BASED C

[3] Sample size calculations for the two-sample problem using the multiplicative intensity model [J].

Bernardo, MVP ;

Harrington, DP .

STATISTICS IN MEDICINE, 2001, 20 (04) :557-579

[4] TESTS OF HYPOTHESES IN OVERDISPERSED POISSON REGRESSION AND OTHER QUASI-LIKELIHOOD MODELS [J].

BRESLOW, N .

JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1990, 85 (410) :565-571

[5]

BRESLOW NE, 1984, APPL STAT-J ROY ST C, V33, P38

[6] THE DESIGN AND ANALYSIS OF RANDOMIZED TRIALS WITH RECURRENT EVENTS [J].

COOK, RJ .

STATISTICS IN MEDICINE, 1995, 14 (19) :2081-2098

[7] Robust tests for treatment comparisons based on recurrent event responses [J].

Cook, RJ ;

Lawless, JF ;

Nadeau, C .

BIOMETRICS, 1996, 52 (02) :557-571

[8] VARIANCE FUNCTION ESTIMATION [J].

DAVIDIAN, M ;

CARROLL, RJ .

JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1987, 82 (400) :1079-1091

[9] Efficiency lost by analyzing counts rather than event times in Poisson and overdispersed Poisson regression models [J].

Dean, CB ;

Balshaw, R .

JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1997, 92 (440) :1387-1398

[10] A CONTROLLED TRIAL OF INTERFERON-GAMMA TO PREVENT INFECTION IN CHRONIC GRANULOMATOUS-DISEASE [J].

EZEKOWITZ, RAB .

NEW ENGLAND JOURNAL OF MEDICINE, 1991, 324 (08) :509-516

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