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Discrete sequential boundaries for clinical trials
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 (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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Metadata
- 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
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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