Cited by 2,310Statistical Methods in Clinical TrialsProbability and Statistical ResearchStatistical Methods and Bayesian Inference

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Discrete sequential boundaries for clinical trials

GORDON LAN, K. K., DEMETS, DAVID L.·1983·Biometrika

DOI 10.1093/biomet/70.3.659

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Abstract

Pocock (1977), O'Brien & Fleming (1979) and Slud & Wei (1982) have proposed different methods to construct discrete sequential boundaries for clinical trials. These methods require that the total number of decision times be specified in advance. In the present paper, we propose a more flexible way to construct discrete sequential boundaries. The method is based on the choice of a function, α*(t), which characterizes the rate at which the error level α is spent. The boundary at a decision time is determined by α*(t), and by past and current decision times, but does not depend on the future decision times or the total number of decision times.

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“Rooted in classical statistical analysis (Wald, 1945b; Jennison and Turnbull, 1999a; Lan and DeMets, 1983; O’Brien and Fleming, 1979), this approach has been widely applied in fields like clinical trials and quality con-trol (Jennison and Turnbull, 1999b).”
Untitled work
Wajchenberg (2000) · doi:10.1002/(sici)1097-0142(20000215)88:4
Untitled work
Walter (1998) · doi:10.1002/(sici)1097-0258(19980115)17:1

Authors: GORDON LAN, K. K., & DEMETS, D. L.
Affiliations: University of Wisconsin–Madison (US)
Venue: Biometrika
Publisher: Oxford University Press (OUP)
Published: 1983
Volume: 70
Issue: 3
Pages: 659-663
ISSN: 0006-3444 (ISSN-L)
1464-3510
DOI: 10.1093/biomet/70.3.659
OpenAlex: W1990639292
Cited by: 2,310
References: 10
Citations by year: 2026: 51 · 2025: 69 · 2024: 80 · 2023: 78 · 2022: 63 · 2021: 73 · 2020: 77 · 2019: 96 · 2018: 76 · 2017: 89 · 2016: 90 · 2015: 72 · 2014: 112 · 2013: 73 · 2012: 101
FWCI: 7.06
Type: journal article
Language: en
Open access: closed
Locations: Biometrika (publishedVersion)
Topics: Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Physical Sciences › Mathematics › Statistics and Probability › Probability and Statistical Research
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
Keywords: clinical trials, early stopping, alpha spending functions, sequential analysis, decision time, error rate control

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Discrete sequential boundaries for clinical trials

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