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

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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  • Sequential testing methods such as Group Sequential Testing and the Sequential Probability Ratio Test have long been used to optimize sample size and decision-making in various fields by evaluating data at interim points.

    “Sequential testing methods, such as Group Sequential Testing (GST) (Jennison and Turnbull, 1999a; Lan and DeMets, 1983; Pocock, 1977; O'Brien and Fleming, 1979) and the Sequential Probability Ratio Test (SPRT) (Wald, 1945c), have long been used to optimize sample size and decision-making in various fields (e.g. clinical trials), by evaluating data at interim points.”

    From Stop Guessing When to Stop Testing: Efficient Model Evaluation with Just Enough Data (2026) · cites this paper as Lan and DeMets, 1983

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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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