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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Crossref · 10.1093/biomet/70.3.659

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A Multiple Testing Procedure for Clinical Trials
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Group sequential methods in the design and analysis of clinical trials
POCOCK, S. J. (1977) · Biometrika · doi:10.1093/biomet/64.2.191 · Cited by 1,831
Repeated Significance Tests on Accumulating Data
Armitage, P., McPherson, C. K., & Rowe, B. C. (1969) · Journal of the Royal Statistical Society Series A (General) · doi:10.2307/2343787 · Cited by 772
Stochastically curtailed tests in long–term clinical trials
Lan, K. K. G., Simon, R. M., & Halperin, M. (1982) · Sequential Analysis · doi:10.1080/07474948208836014 · Cited by 356
Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach
Pocock, S. (1982) · Biometrics · doi:10.2307/2530298 · Cited by 265
Two-Sample Repeated Significance Tests Based on the Modified Wilcoxon Statistic
SLUD, E. V., & Wei, L. (1982) · Journal of the American Statistical Association · doi:10.1080/01621459.1982.10477899 · Cited by 244
Crossing probabilities for a square root boundary by a bessel process
Long, D. M. D. (1981) · Communication in Statistics- Theory and Methods · doi:10.1080/03610928108828182 · Cited by 135
Sequential Testing of the Equality of Two Survival Distributions Using the Modified Savage Statistic
Koziol, J. A., & Petkau, A. J. (1978) · Biometrika · doi:10.1093/biomet/65.3.615 · Cited by 38
A two sample wilcoxon test for progressively censored data
DAVIS, C. E. (1978) · Communication in Statistics- Theory and Methods · doi:10.1080/03610927808827630 · Cited by 23
Rank order tests for grouped data under progressive censoring
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Wapner, R. J., Sorokin, Y., Thom, E. A., Johnson, F. F., Dudley, D. J., Spong, C. Y., Peaceman, A. M., Leveno, K. J., Harper, M., Caritis, S. N., et al. (2006) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2006.03.087 · Cited by 292
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Kline, J. A., Nordenholz, K. E., Courtney, D. M., Kabrhel, C., Jones, A. E., Rondina, M. T., Diercks, D. B., Klinger, J. R., & Hernandez‐Nino, J. (2014) · Journal of Thrombosis and Haemostasis · doi:10.1111/jth.12521 · Cited by 287
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Ginde (2019) · doi:10.1056/nejmoa1911124 · Cited by 286
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Kato, K., Machida, R., Ito, Y., Daiko, H., Ozawa, S., Ogata, T., Hara, H., Kojima, T., Abe, T., Bamba, T., et al. (2024) · The Lancet · doi:10.1016/s0140-6736(24)00745-1 · Cited by 300
Maintenance of sinus rhythm in patients with atrial fibrillation
The AFFIRM First Antiarrhythmic Drug Substudy Investigators (2003) · Journal of the American College of Cardiology · doi:10.1016/s0735-1097(03)00559-x · Cited by 281
Interpreting meta-analysis according to the adequacy of sample size. An example using isoniazid chemoprophylaxis for tuberculosis in purified protein derivative negative HIV-infected individuals
Mills (2010) · Clinical Epidemiology · doi:10.2147/clep.s9242 · Cited by 281
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Feldblum, P. J., Adeiga, A., Bakare, R., Wevill, S., Lendvay, A., Obadaki, F., Olayemi, M. O., Wang, L., Nanda, K., & Rountree, W. (2008) · PLoS ONE · doi:10.1371/journal.pone.0001474 · Cited by 280
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Gupta, A. K., Gonzalez‐Rojas, Y., Juarez, E., Casal, M. C., Moya, J., Falci, D. R., Sarkis, E. H., Solis, J., Zheng, H., Scott, N. E., et al. (2022) · JAMA · doi:10.1001/jama.2022.2832 · Cited by 277
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Siegel, D. S. D., Dimopoulos, M. A., Ludwig, H., Facon, T. T. F., Goldschmidt, H., Jakubowiak, A. J., Miguel, J. F. S., Obreja, M., Blædel, J., & Stewart, A. K. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2017.76.5032 · Cited by 272
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Friedman, D. L., Chen, L., Wolden, S. L., Buxton, A. B., McCarten, K. M., FitzGerald, T. J., Kessel, S., de Alarcón, P. A., Chen, A. R., Kobrinsky, N. L., et al. (2014) · Journal of Clinical Oncology · doi:10.1200/jco.2013.52.5410 · Cited by 269
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Lamas, G. A., Goertz, C., Boineau, R., Mark, D. B., Rozema, T. C., Nahin, R. L., Lindblad, L., Lewis, E. F., Drisko, J., Lee, K. L., et al. (2013) · JAMA · doi:10.1001/jama.2013.2107 · Cited by 269
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Bloos, F., Trips, E., Nierhaus, A., Briegel, J., Heyland, D. K., Jaschinski, U., Moerer, O., Weyland, A., Marx, G., Gründling, M., et al. (2016) · JAMA Internal Medicine · doi:10.1001/jamainternmed.2016.2514 · Cited by 268
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Maron, D. J., Hochman, J. S., O’Brien, S. M., Reynolds, H. R., Boden, W. E., Stone, G. W., Bangalore, S., Spertus, J. A., Mark, D. B., Alexander, K. P., et al. (2018) · American Heart Journal · doi:10.1016/j.ahj.2018.04.011 · Cited by 259
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Gordin, F. M. (2000) · JAMA · doi:10.1001/jama.283.11.1445 · Cited by 262
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Moore, E. E., Moore, F. A., Fabian, T. C., Bernard, A. C., Fulda, G. J., Hoyt, D. B., Duane, T. M., Weireter, L. J., Gómez, G. A., Cipolle, M. D., et al. (2008) · Journal of the American College of Surgeons · doi:10.1016/j.jamcollsurg.2008.09.023 · Cited by 260
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Wilhelmus, K. R., Gee, L., Hauck, W. W., Kurinij, N., Dawson, C. R., Jones, D. B., Barron, B., Kaufman, H. E., Sugar, J., Hyndiuk, R. A., et al. (1994) · Ophthalmology · doi:10.1016/s0161-6420(94)31087-6 · Cited by 259
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Freedman, B. I., Wuerth, J.-P., Cartwright, K. J., Bain, R. P., Dippe, S. E., Hershon, K. S., Mooradian, A. D., & Spinowitz, B. (1999) · Controlled Clinical Trials · doi:10.1016/s0197-2456(99)00024-0 · Cited by 257
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Nakachi, K., Ikeda, M., Konishi, M., Nomura, S., Katayama, H., Kataoka, T., Todaka, A., Yanagimoto, H., Morinaga, S., Kobayashi, S., et al. (2023) · The Lancet · doi:10.1016/s0140-6736(22)02038-4 · Cited by 258
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Cook, R. J., & Farewell, V. T. (1996) · Journal of the Royal Statistical Society Series A (Statistics in Society) · doi:10.2307/2983471 · Cited by 257
When to stop a clinical trial.
Pocock, S. J. (1992) · BMJ · doi:10.1136/bmj.305.6847.235 · Cited by 255
Exemestane Versus Anastrozole in Postmenopausal Women With Early Breast Cancer: NCIC CTG MA.27—A Randomized Controlled Phase III Trial
Goss, P. E., Ingle, J. N., Pritchard, K. I., Ellis, M. J., Sledge, G. W., Budd, G. T., Rabaglio, M., Ansari, R., Johnson, D. B., Tozer, R. G., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.44.7805 · Cited by 257
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Binneman, B., Feltner, D., Kolluri, S., Shi, Y., Qiu, R., & Stiger, T. (2008) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2008.07071199 · Cited by 254
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Arnold, R., Rinke, A., Klose, K., Müller, H., Wied, M., Zamzow, K., Schmidt, C., Schade‐Brittinger, C., Barth, P. J., Moll, R., et al. (2005) · Clinical Gastroenterology and Hepatology · doi:10.1016/s1542-3565(05)00481-7 · Cited by 254
Group sequential designs using a family of type I error probability spending functions
Hwang, I. K., Shih, W. J., & de Cani, J. S. (1990) · Statistics in Medicine · doi:10.1002/sim.4780091207 · Cited by 247
Interim Analyses: The Repeated Confidence Interval Approach
Jennison, C., & Turnbull, B. W. (1989) · Journal of the Royal Statistical Society Series B (Statistical Methodology) · doi:10.1111/j.2517-6161.1989.tb01433.x · Cited by 246
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Importance of bleomycin in favorable-prognosis disseminated germ cell tumors: an Eastern Cooperative Oncology Group trial.
Loehrer, P. J., Johnson, D. H., Elson, P. J., Einhorn, L. H., & Trump, D. L. (1995) · Journal of Clinical Oncology · doi:10.1200/jco.1995.13.2.470 · Cited by 244
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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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