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

The DOI matches its Crossref record; 10 of the 10 references it cites were found in a registry or an index.

Discrete sequential boundaries for clinical trials

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

DOI 10.1093/biomet/70.3.659

Open this paper in CoChat — free account

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.

Integrity signals

Registry

Crossref · 10.1093/biomet/70.3.659

Cites

10 of 10 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

This paper’s full text isn’t openly available, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

A Multiple Testing Procedure for Clinical Trials
O'Brien, P. C., & Fleming, T. R. (1979) · Biometrics · doi:10.2307/2530245 · Cited by 3,311
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
Majumdar, H., & Sen, P. K. (1977) · Communication in Statistics- Theory and Methods · doi:10.1080/03610927708827511 · Cited by 9

Show all 10 references

Sorted by citations

Items 301–400 of 1,001

Levetiracetam for the treatment of idiopathic generalized epilepsy with myoclonic seizures
Noachtar, S., Andermann, E., Meyvisch, P., Andermann, F., Gough, W. B., & Schiemann‐Delgado, J. (2008) · Neurology · doi:10.1212/01.wnl.0000297512.18364.40 · Cited by 242
Multiple testing in clinical trials
Bauer, P. (1991) · Statistics in Medicine · doi:10.1002/sim.4780100609 · Cited by 241
Radial Artery Grafts vs Saphenous Vein Grafts in Coronary Artery Bypass Surgery
Goldman, S. (2011) · JAMA · doi:10.1001/jama.2010.1976 · Cited by 240
Herpetic Eye Disease Study
Barron, B., Gee, L., Hauck, W. W., Kurinij, N., Dawson, C. R., Jones, D. B., Wilhelmus, K. R., Kaufman, H. E., Sugar, J., Hyndiuk, R. A., et al. (1994) · Ophthalmology · doi:10.1016/s0161-6420(13)31155-5 · Cited by 238
Thoracic radiotherapy with or without daily low-dose carboplatin in elderly patients with non-small-cell lung cancer: a randomised, controlled, phase 3 trial by the Japan Clinical Oncology Group (JCOG0301)
Atagi, S., Kawahara, M., Yokoyama, A., Okamoto, H., Yamamoto, N., Ohe, Y., Sawa, T., Ishikura, S., Shibata, T., Fukuda, H., et al. (2012) · The Lancet Oncology · doi:10.1016/s1470-2045(12)70139-0 · Cited by 238
Sequence of hormonal therapy and radiotherapy field size in unfavourable, localised prostate cancer (NRG/RTOG 9413): long-term results of a randomised, phase 3 trial
Roach, M., Moughan, J., Lawton, C. A., Dicker, A. P., Zeitzer, K. L., Gore, E., Kwok, Y., Seider, M. J., Hsu, I.-C. J., Hartford, A. C., et al. (2018) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30528-x · Cited by 236
Effects at Two Years of a Low-Fat, High-Carbohydrate Diet on Radiologic Features of the Breast: Results From a Randomized Trial
Boyd, N. F., Greenberg, C. C., Lockwood, G., Little, L., Martin, L. J., Tritchler, D., Byng, J. W., & Yaffe, M. J. (1997) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/89.7.488 · Cited by 236
Heart Failure and A Controlled Trial Investigating Outcomes of Exercise TraiNing (HF-ACTION): Design and rationale
Whellan, D. J., O’Connor, C. M., Lee, K. L., Keteyian, S. J., Cooper, L. S., Ellis, S. J., Leifer, E., Kraus, W. E., Kitzman, D. W., Blumenthal, J. A., et al. (2007) · American Heart Journal · doi:10.1016/j.ahj.2006.11.007 · Cited by 235
On the inefficiency of the adaptive design for monitoring clinical trials
Tsiatis, A. A. (2003) · Biometrika · doi:10.1093/biomet/90.2.367 · Cited by 233
The Quinapril Ischemic Event Trial (QUIET): evaluation of chronic ace inhibitor therapy in patients with ischemic heart disease and preserved left ventricular function
Pitt, B., O’Neill, B. J., Feldman, R., Ferrari, R., Schwartz, L., Mudra, H. G., Bass, T. A., Pepine, C. J., Texter, M. J., Haber, H. E., et al. (2001) · The American Journal of Cardiology · doi:10.1016/s0002-9149(01)01461-8 · Cited by 228
Rationale and design of a randomized clinical trial of β-blocker therapy (atenolol) versus angiotensin II receptor blocker therapy (losartan) in individuals with Marfan syndrome
Lacro, R. V., Dietz, H. C., Wruck, L. M., Bradley, T. J., Colan, S. D., Devereux, R. B., Klein, G. L., Li, J. S., Minich, L. L., Paridon, S. M., et al. (2007) · American Heart Journal · doi:10.1016/j.ahj.2007.06.024 · Cited by 229
A review of methods for futility stopping based on conditional power
Lachin, J. M. (2005) · Statistics in Medicine · doi:10.1002/sim.2151 · Cited by 228
The Effect of Cardiac Resynchronization on Morbidity and Mortality in Heart Failure
Cleland, J. G. F., Daubert, C., & Erdmann, E. (2005) · ACC Current Journal Review · doi:10.1016/j.accreview.2005.05.046 · Cited by 236
Mortality in Patients After a Recent Myocardial Infarction
Camm, A. J., Pratt, C. M., Schwartz, P. J., Al‐Khalidi, H. R., Spyt, M. J., Holroyde, M. J., Karam, R., Sonnenblick, E. H., & Brum, J. M. (2004) · Circulation · doi:10.1161/01.cir.0000117090.01718.2a · Cited by 226
Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink
Gee, J. M., Naleway, A. L., Shui, I. M., Baggs, J. M., Yin, R., Li, R., Kulldorff, M., Lewis, E. M., FIREMAN, B. H., Daley, M. F., et al. (2011) · Vaccine · doi:10.1016/j.vaccine.2011.08.106 · Cited by 237
Famotidine for the prevention of peptic ulcers and oesophagitis in patients taking low-dose aspirin (FAMOUS): a phase III, randomised, double-blind, placebo-controlled trial
Taha, A. S., McCloskey, C., Prasad, R., & Bezlyak, V. (2009) · The Lancet · doi:10.1016/s0140-6736(09)61246-0 · Cited by 226
Parameter Estimation Following Group Sequential Hypothesis Testing
Emerson, S. S., & Fleming, T. R. (1990) · Biometrika · doi:10.1093/biomet/77.4.875 · Cited by 225
Department of Veterans Affairs Cooperative Studies Program Clinical Trial Comparing Combined Warfarin and Aspirin With Aspirin Alone in Survivors of Acute Myocardial Infarction: Primary Results of the CHAMP Study
Fiore, L. D., Ezekowitz, M. D., Brophy, M. T., Lu, D., Sacco, J., & Peduzzi, P. (2002) · Circulation · doi:10.1161/hc0502.103329 · Cited by 224
Zoledronate in combination with chemotherapy and surgery to treat osteosarcoma (OS2006): a randomised, multicentre, open-label, phase 3 trial
Piperno-Neumann, S., Deley, M. L., Rédiní, F., Pacquement, H., Marec‐Bérard, P., Petit, P., Brisse, H. J., Lervat, C., Gentet, J., Entz‐Werlé, N., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(16)30096-1 · Cited by 218
Early administration of intravenous magnesium to high-risk patients with acute myocardial infarction in the Magnesium in Coronaries (MAGIC) Trial: a randomised controlled trial
Antman, E. M. (2002) · The Lancet · doi:10.1016/s0140-6736(02)11278-5 · Cited by 219
Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis
Pampallona, S., & Tsiatis, A. A. (1994) · Journal of Statistical Planning and Inference · doi:10.1016/0378-3758(94)90187-2 · Cited by 219
Effect of Aspirin on Development of ARDS in At-Risk Patients Presenting to the Emergency Department
Kor, D. J., Carter, R. E., Park, P. K., Festić, E., Banner‐Goodspeed, V., Hinds, R. F., Talmor, D. S., Gajic, O., Ware, L. B., Gong, M. N., et al. (2016) · JAMA · doi:10.1001/jama.2016.6330 · Cited by 219
Effect of the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation Therapy for Patients With Esophageal Cancer
Suntharalingam, M., Winter, K. A., Ilson, D. H., Dicker, A. P., Kachnic, L. A., Konski, A. A., Chakravarthy, A. B., Anker, C. J., Thakrar, H. V., Horiba, N., et al. (2017) · JAMA Oncology · doi:10.1001/jamaoncol.2017.1598 · Cited by 217
PET-adapted treatment for newly diagnosed advanced Hodgkin lymphoma (AHL2011): a randomised, multicentre, non-inferiority, phase 3 study
Casasnovas, O., Bouabdallah, R., Brice, P., Lazarovici, J., Ghesquières, H., Stamatoullas, A., Dupuis, J., Gac, A., Gastinne, T., Joly, B., et al. (2019) · The Lancet Oncology · doi:10.1016/s1470-2045(18)30784-8 · Cited by 217
Effect of Bevacizumab vs Aflibercept on Visual Acuity Among Patients With Macular Edema Due to Central Retinal Vein Occlusion
Scott, I. U., VanVeldhuisen, P., Ip, M. S., Blodi, B. A., Oden, N. L., Awh, C. C., Kunimoto, D. Y., Marcus, D. M., Wroblewski, J. J., King, J. S., et al. (2017) · JAMA · doi:10.1001/jama.2017.4568 · Cited by 215
Effect of Oral Insulin on Prevention of Diabetes in Relatives of Patients With Type 1 Diabetes: A Randomized Clinical Trial
Writing Committee for the Type 1 Diabetes TrialNet Oral Insulin Study Group, Krischer, J. P., Schatz, D. A., Bundy, B., Skyler, J. S., & Greenbaum, C. J. (2017) · JAMA · doi:10.1001/jama.2017.17070 · Cited by 214
Integrating Tobacco Cessation Into Mental Health Care for Posttraumatic Stress Disorder A Randomized Controlled Trial
McFall, M. (2010) · JAMA · doi:10.1001/jama.2010.1769 · Cited by 213
Vitamin D supplementation for prevention of cancer in adults
Bjelaković, G., Gluud, L. L., Nikolova, D., Whitfield, K., Krstic, G., Wetterslev, J., & Gluud, C. N. (2014) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007469.pub2 · Cited by 216
Weekly Cisplatin Plus Radiation for Postoperative Head and Neck Cancer (JCOG1008): A Multicenter, Noninferiority, Phase II/III Randomized Controlled Trial
Kiyota, N., Tahara, M., Mizusawa, J., Kodaira, T., Fujii, H., Yamazaki, T., Mitani, H., Iwae, S., Fujimoto, Y., Onozawa, Y., et al. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.21.01293 · Cited by 213
Increasing the sample size when the unblinded interim result is promising
Chen, Y. H. J., DeMets, D. L., & Lan, K. K. G. (2004) · Statistics in Medicine · doi:10.1002/sim.1688 · Cited by 208
Self-citation
Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial
Häussinger, K. (2005) · Thorax · doi:10.1136/thx.2005.041475 · Cited by 207
Tisotumab Vedotin as Second- or Third-Line Therapy for Recurrent Cervical Cancer
Vergote, I. B., González-Martín, A., Fujiwara, K., Kalbacher, E., Bagaméri, A., Ghamande, S. A., Lee, J., Banerjee, S. N., Maluf, F. C., Lorusso, D., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2313811 · Cited by 207
Psychometrics Behind Computerized Adaptive Testing
Chang, H. (2014) · Psychometrika · doi:10.1007/s11336-014-9401-5 · Cited by 206
Angiotensin II–Receptor Inhibition With Candesartan to Prevent Trastuzumab-Related Cardiotoxic Effects in Patients With Early Breast Cancer
Boekhout, A. H., Gietema, J. A., Kerklaan, B. M., van Werkhoven, E. D., Altena, R., Honkoop, A. H., Los, M., Smit, W. M., Nieboer, P., Smorenburg, C. H., et al. (2016) · JAMA Oncology · doi:10.1001/jamaoncol.2016.1726 · Cited by 207
Sequential designs for phase III clinical trials incorporating treatment selection
Stallard, N., & Todd, S. (2003) · Statistics in Medicine · doi:10.1002/sim.1362 · Cited by 203
Adaptive enrichment designs for clinical trials
Simon, N., & Simon, R. (2013) · Biostatistics · doi:10.1093/biostatistics/kxt010 · Cited by 202
Interim Analyses in Randomized Clinical Trials: Ramifications and Guidelines for Practitioners
Geller, N. L., & Pocock, S. (1987) · Biometrics · doi:10.2307/2531962 · Cited by 202
Targeting intensive glycaemic control versus targeting conventional glycaemic control for type 2 diabetes mellitus
Hemmingsen, B., Lund, S. S., Gluud, C. N., Vaag, A. A., Almdal, T., & Wetterslev, J. (2013) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008143.pub3 · Cited by 210
Retracted
Randomized trial of combination versus monotherapy for the empiric treatment of suspected ventilator-associated pneumonia*
Heyland, D. K., Dodek, P., Muscedere, J., Day, A. G., & Cook, D. (2008) · Critical Care Medicine · doi:10.1097/01.ccm.0b013e31816203d6 · Cited by 201
Off-pump versus on-pump coronary artery bypass grafting for ischaemic heart disease
Møller, C. H., Penninga, L., Wetterslev, J., Steinbrüchel, D. A., & Gluud, C. N. (2012) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd007224.pub2 · Cited by 200
The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial
Velazquez, E. J., Lee, K. L., O’Connor, C. M., Oh, J. K., Bonow, R. O., Pohost, G. M., Feldman, A. M., Mark, D. B., Panza, J. A., Sopko, G. S., et al. (2007) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2007.05.069 · Cited by 200
Five-Year Survival Outcomes of Laparoscopy-Assisted vs Open Distal Gastrectomy for Advanced Gastric Cancer
Etoh, T., Ohyama, T., Sakuramoto, S., Tsuji, T., Lee, S., Yoshida, K., Koeda, K., Hiki, N., Kunisaki, C., Tokunaga, M., et al. (2023) · JAMA Surgery · doi:10.1001/jamasurg.2023.0096 · Cited by 199
Viscum album [L.] extract therapy in patients with locally advanced or metastatic pancreatic cancer: A randomised clinical trial on overall survival
Tröger, W., Galun, D. A., Reif, M., Schumann, A., Stanković, N., & Milicevic, M. (2013) · European Journal of Cancer · doi:10.1016/j.ejca.2013.06.043 · Cited by 199
Primary Tumor Resection Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastases (JCOG1007; iPACS): A Randomized Clinical Trial
Kanemitsu, Y., Shitara, K., Mizusawa, J., Hamaguchi, T., Shida, D., Komori, K., Ikeda, S., Ojima, H., Ike, H., Shiomi, A., et al. (2021) · Journal of Clinical Oncology · doi:10.1200/jco.20.02447 · Cited by 198
Randomized Clinical Trial of Metronidazole Plus Erythromycin to Prevent Spontaneous Preterm Delivery in Fetal Fibronectin–Positive Women
Andrews, W. W., Sibai, B. M., Thom, E. A., Dudley, D. J., Ernest, J. M., McNellis, D., Leveno, K. J., Wapner, R. J., Moawad, A., O’Sullivan, M. J., et al. (2003) · Obstetrics and Gynecology · doi:10.1016/s0029-7844(03)00172-8 · Cited by 196
Association of Nonoperative Management Using Antibiotic Therapy vs Laparoscopic Appendectomy With Treatment Success and Disability Days in Children With Uncomplicated Appendicitis
Minneci, P. C., Hade, E. M., Lawrence, A. E., Sebastião, Y. V., Saito, J. M., Mak, G. Z., Fox, C., Hirschl, R. B., Gadepalli, S. K., Helmrath, M. A., et al. (2020) · JAMA · doi:10.1001/jama.2020.10888 · Cited by 195
Randomized, Placebo-Controlled, Phase III Trial of Sunitinib Plus Prednisone Versus Prednisone Alone in Progressive, Metastatic, Castration-Resistant Prostate Cancer
Michaelson, M. D., Oudard, S. M., Ou, Y.-C., Sengeløv, L., Fred Saad, C., Houédé, N., Ostler, P. J., Stenzl, A., Daugaard, G., Jones, R. J., et al. (2013) · Journal of Clinical Oncology · doi:10.1200/jco.2012.48.5268 · Cited by 197
A prospective, randomised and blinded comparison of first shock success of monophasic and biphasic waveforms in out-of-hospital cardiac arrest
van Alem, A. P., Chapman, F. W., Lank, P., Hart, A. A. M., & Koster, R. W. (2003) · Resuscitation · doi:10.1016/s0300-9572(03)00106-0 · Cited by 194
Homocysteine-Lowering and Cardiovascular Disease Outcomes in Kidney Transplant Recipients
Bostom, A. G., Carpenter, M. A., Kusek, J. W., Levey, A. S., Hunsicker, L. G., Pfeffer, M. A., Selhub, J., Jacques, P. F., Cole, E., Gravens‐Mueller, L., et al. (2011) · Circulation · doi:10.1161/circulationaha.110.000588 · Cited by 191
Intralesional Immunotherapy of Warts With Mumps, Candida, and Trichophyton Skin Test Antigens
Horn, T. D., Johnson, S. M., Helm, R. M., & Roberson, P. K. (2005) · Archives of Dermatology · doi:10.1001/archderm.141.5.589 · Cited by 193
Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
Farkouh, M. E., Dangas, G., Leon, M. B., Smith, C. R., Nesto, R. W., Buse, J. B., Cohen, D. J., Mahoney, E. M., Sleeper, L. A., King, S. B., et al. (2008) · American Heart Journal · doi:10.1016/j.ahj.2007.10.012 · Cited by 190
Filgrastim improves survival in lethally irradiated nonhuman primates
Farese, A. M., Cohen, M. V., Katz, B. P., Smith, C. P., Gibbs, A., Cohen, D. M., & MacVittie, T. J. (2013) · Radiation Research · doi:10.1667/rr3049.1 · Cited by 187
A Controlled Trial of Intravenous Immune Globulin to Reduce Nosocomial Infections in Very-Low-Birth-Weight Infants
Fanaroff, A. A., Korones, S. B., Wright, L. L., Wright, E. C., Poland, R. L., Bauer, C. R., Tyson, J. E., Philips, J. B., Edwards, W. H., Lucey, J. F., et al. (1994) · New England Journal of Medicine · doi:10.1056/nejm199404213301602 · Cited by 187
Randomized Phase III Intergroup Trial of Etoposide and Cisplatin With or Without Paclitaxel and Granulocyte Colony-Stimulating Factor in Patients With Extensive-Stage Small-Cell Lung Cancer: Cancer and Leukemia Group B Trial 9732
Niell, H. B., Herndon, J. E., Miller, A. A., Watson, D. M., Sandler, A. B., Kelly, K. L., Marks, R. S., Perry, M. C., Ansari, R., Otterson, G. A., et al. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.09.071 · Cited by 187
Studies of Left Ventricular Dysfunction (SOLVD)—Rationale, design and methods: Two trials that evaluate the effect of enalapril in patients with reduced ejection fraction
The SOLVD Investigators (1990) · The American Journal of Cardiology · doi:10.1016/0002-9149(90)90842-o · Cited by 187
Neurologic Function and Health-Related Quality of Life in Patients Following Targeted Temperature Management at 33°C vs 36°C After Out-of-Hospital Cardiac Arrest
Cronberg, T., Lilja, G., Horn, J., Kjærgaard, J., Wise, M. P., Pellis, T., Hovdenes, J., Gasche, Y. G., Åneman, A., Stammet, P., et al. (2015) · JAMA Neurology · doi:10.1001/jamaneurol.2015.0169 · Cited by 183
The CASCADE study: Randomized antiarrhythmic drug therapy in survivors of Cardiac Arrest in Seattle
Greene, H. L., & The CASCADE Investigators (1993) · The American Journal of Cardiology · doi:10.1016/0002-9149(93)90966-g · Cited by 186
Belantamab Mafodotin, Pomalidomide, and Dexamethasone in Multiple Myeloma
Dimopoulos, M. A., Beksac, M., Pour, L., Delimpasi, S., Vorobyev, V., Quach, H., Spicka, I., Radocha, J., Robak, P., Kim, K., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2403407 · Cited by 189
Meta-regression analyses, meta-analyses, and trial sequential analyses of the effects of supplementation with beta-carotene, vitamin A, and vitamin E singly or in different combinations on all-cause mortality: do we have evidence for lack of harm?
Bjelakovic, G., Nikolova, D., & Gluud, C. (2013) · PLoS ONE · doi:10.1371/journal.pone.0074558 · Cited by 183
Statistical Approaches to Interim Monitoring of Medical Trials: A Review and Commentary
Jennison, C., & Turnbull, B. W. (1990) · Statistical Science · doi:10.1214/ss/1177012099 · Cited by 180
Reporting delay and corrected incidence of multiple sclerosis
Esbjerg, S., Keiding, N., & Koch‐Henriksen, N. (1999) · Statistics in Medicine · doi:10.1002/(sici)1097-0258(19990715)18:13 · Cited by 38
Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery
Bove, T., Zangrillo, A., Guarracino, F., Alvaro, G., Persi, B., Maglioni, E., Galdieri, N., Comis, M., Caramelli, F., Pasero, D., et al. (2014) · JAMA · doi:10.1001/jama.2014.13573 · Cited by 181
Parenteral Glutamine Supplementation Does Not Reduce the Risk of Mortality or Late-Onset Sepsis in Extremely Low Birth Weight Infants
Poindexter, B. B., Ehrenkranz, R. A., Stoll, B. J., Wright, L. L., Poole, W. K., Oh, W., Bauer, C. R., Papile, L. A., Tyson, J. E., Carlo, W. A., et al. (2004) · PEDIATRICS · doi:10.1542/peds.113.5.1209 · Cited by 181
ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer
Powles, T. B., Kann, A. G., Castellano, D., Gross‐Goupil, M., Nishiyama, H., Sergio Bracarda, A., Jensen, J. B., Makaroff, L., Jiang, S., Ku, J. H., et al. (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2511885 · Cited by 199
Effect of Folic Acid and Zinc Supplementation in Men on Semen Quality and Live Birth Among Couples Undergoing Infertility Treatment
Schisterman, E. F., Sjaarda, L. A., Clemons, T., Carrell, D. T., Perkins, N. J., Johnstone, E., Lamb, D., Chaney, K., Van Voorhis, B. J., Ryan, G., et al. (2020) · JAMA · doi:10.1001/jama.2019.18714 · Cited by 179
Reduction of Iron Stores and Cardiovascular Outcomes in Patients With Peripheral Arterial Disease
Zacharski, L. R., Chow, B. K., Howes, P. S., Shamayeva, G., Baron, J. A., Dalman, R. L., Malenka, D. J., Ozaki, C. K., & Lavori, P. W. (2007) · JAMA · doi:10.1001/jama.297.6.603 · Cited by 180
Effect of Statin Therapy on Mortality in Patients With Ventilator-Associated Pneumonia
Papazian, L. (2013) · JAMA · doi:10.1001/jama.2013.280031 · Cited by 177
Design of the Fracture Intervention Trial
Black, D. M., Reiss, T. F., Nevitt, M. C., Cauley, J. A., Karpf, D. B., & Cummings, S. R. (1993) · Osteoporosis International · doi:10.1007/bf01623005 · Cited by 175
Associations between parental psychological control and relational aggression in children and adolescents: A multilevel and sequential meta-analysis.
Kuppens, S., Laurent, L., Heyvaert, M., & Onghena, P. (2012) · Developmental Psychology · doi:10.1037/a0030740 · Cited by 177
The use of del Nido cardioplegia in adult cardiac surgery: A prospective randomized trial
Ad, N., Holmes, S. D., Massimiano, P. S., Rongione, A. J., Fornaresio, L. M., & Fitzgerald, D. C. (2017) · Journal of Thoracic and Cardiovascular Surgery · doi:10.1016/j.jtcvs.2017.09.146 · Cited by 175
Increased Long-Term Mortality After a High Perioperative Inspiratory Oxygen Fraction During Abdominal Surgery: Follow-Up of a Randomized Clinical Trial
Meyhoff, C., Jørgensen, L., Wetterslev, J., Christensen, K., & Rasmussen, L. (2012) · Anesthesia and Analgesia · doi:10.1213/ane.0b013e3182652a51 · Cited by 165
A Multicenter Trial of Two Dexamethasone Regimens in Ventilator-Dependent Premature Infants
Papile, L. A., Tyson, J. E., Stoll, B. J., Wright, L. L., Donovan, E. F., Bauer, C. R., Krause-Steinrauf, H. J., Verter, J. I., Korones, S. B., Lemons, J. A., et al. (1998) · New England Journal of Medicine · doi:10.1056/nejm199804163381604 · Cited by 168
Rationale and Design of the Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan (EVEREST)
Gheorghiade, M., Orlandi, C., Burnett, J. C. J., DeMets, D. L., Grinfeld, L. R., Maggioni, A. P., Swedberg, K. B., Udelson, J. E., Zannad, F. M., Zimmer, C., et al. (2005) · Journal of Cardiac Failure · doi:10.1016/j.cardfail.2005.03.009 · Cited by 171
Self-citation
High-Dose Chemotherapy and Blood Autologous Stem-Cell Rescue Compared With Standard Chemotherapy in Localized High-Risk Ewing Sarcoma: Results of Euro-E.W.I.N.G.99 and Ewing-2008
Whelan, J. S., Deley, M. L., Dirksen, U., Teuff, G. L., Brennan, B. M. D., Gaspar, N., Hawkins, D. S., Amler, S., Bauer, S., Bielack, S., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.78.2516 · Cited by 171
EV-301 long-term outcomes: 24-month findings from the phase III trial of enfortumab vedotin versus chemotherapy in patients with previously treated advanced urothelial carcinoma
Rosenberg, J. E., Powles, T. B., Sonpavde, G., Loriot, Y., Durán, I., Lee, J.-L., Matsubara, N., Vulsteke, C., Castellano, D., Mamtani, R., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2023.08.016 · Cited by 171
Adaptive Modifications of Hypotheses After an Interim Analysis
Hommel, G. (2001) · Biometrical Journal · doi:10.1002/1521-4036(200109)43:5 · Cited by 170
Pharmacological treatment of social anxiety disorder: A meta-analysis
Blanco, C., Schneier, F. R., Schmidt, A. B., Blanco-Jerez, C.-R., Marshall, R. D., Sánchez-Lacay, A., & Liebowitz, M. R. (2003) · Depression and Anxiety · doi:10.1002/da.10096 · Cited by 173
Semiparametric Efficiency and Its Implication on the Design and Analysis of Group-Sequential Studies
Scharfstein, D. O., Tsiatis, A. A., & Robins, J. M. (1997) · Journal of the American Statistical Association · doi:10.1080/01621459.1997.10473655 · Cited by 170
Rationale, study design and implementation of the COLM study: the combination of OLMesartan and calcium channel blocker or diuretic in high-risk elderly hypertensive patients
on behalf of the COLM study investigators, Ogihara, T., Saruta, T., Rakugi, H., Shimamoto, K., Ito, S., Matsuoka, H., Horiuchi, M., Imaizumi, T., Takishita, S., et al. (2009) · Hypertension Research · doi:10.1038/hr.2008.31 · Cited by 169
Surgery versus conservative management for recurrent and ongoing left-sided diverticulitis (DIRECT trial): an open-label, multicentre, randomised controlled trial
van de Wall, B. J. M., Stam, M. A. W., Draaisma, W. A., Stellato, R. K., Bemelman, W. A., Boermeester, M. A., Broeders, I. A. M. J., Belgers, E. J., Toorenvliet, B. R., Prins, H. A., et al. (2016) · The Lancet. Gastroenterology & hepatology · doi:10.1016/s2468-1253(16)30109-1 · Cited by 169
Statistical issues and challenges in immuno-oncology
Chen, T. (2013) · Journal for ImmunoTherapy of Cancer · doi:10.1186/2051-1426-1-18 · Cited by 167
Group sequential procedures: Calendar versus information time
Lan, K. K. G., & DeMets, D. L. (1989) · Statistics in Medicine · doi:10.1002/sim.4780081003 · Cited by 168
Self-citation
Early Inhaled Glucocorticoid Therapy to Prevent Bronchopulmonary Dysplasia
Cole, C. H., Colton, T., Shah, B. L., Abbasi, S., MacKinnon, B. L., Demissie, S., & Frantz, I. D. (1999) · New England Journal of Medicine · doi:10.1056/nejm199904013401304 · Cited by 168
Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial
Iwasaki, Y., Terashima, M., Mizusawa, J., Katayama, H. G., Nakamura, K., Katai, H., Yoshikawa, T., Ito, S., Kaji, M., Kimura, Y., et al. (2020) · Gastric Cancer · doi:10.1007/s10120-020-01136-7 · Cited by 167
Prophylactic intravenous use of milrinone after cardiac operation in pediatrics (PRIMACORP) study
Hoffman, T. M., Wernovsky, G., Atz, A. M., Bailey, J. M., Akbary, A., Kocsis, J. F., Nelson, D. P., Chang, A. C., Kulik, T. J., Spray, T. L., et al. (2002) · American Heart Journal · doi:10.1067/mhj.2002.120305 · Cited by 167
Evolution of the HALT-C Trial: pegylated interferon as maintenance therapy for chronic hepatitis C in previous interferon nonresponders
Lee, W. M., Dienstag, J. L., Lindsay, K. L., Lok, A. S.-F., Bonkovsky, H. L., Shiffman, M. L., Everson, G. T., Bisceglie, A. M. D., Morgan, T. R. M., Ghany, M. G., et al. (2004) · Controlled Clinical Trials · doi:10.1016/j.cct.2004.08.003 · Cited by 167
The effects of high perioperative inspiratory oxygen fraction for adult surgical patients
Wetterslev, J., Meyhoff, C. S., Jørgensen, L. N., Gluud, C. N., Lindschou, J., & Rasmussen, L. S. (2015) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd008884.pub2 · Cited by 165
Target temperature management after out-of-hospital cardiac arrest—a randomized, parallel-group, assessor-blinded clinical trial—rationale and design
Nielsen, N., Wetterslev, J., Al-Subaie, N., Andersson, B., Bro‐Jeppesen, J., Bishop, G., Brunetti, I., Cranshaw, J. H., Cronberg, T., Edqvist, K., et al. (2012) · American Heart Journal · doi:10.1016/j.ahj.2012.01.013 · Cited by 164
Antiarrhythmics Versus Implantable Defibrillators (AVID)—Rationale, design, and methods
The AVID Investigators (1995) · The American Journal of Cardiology · doi:10.1016/s0002-9149(99)80583-9 · Cited by 164
Efficacy of a Hip Protector to Prevent Hip Fracture in Nursing Home Residents
Kiel, D. P., Magaziner, J. S., Zimmerman, S. I., Ball, L., BARTON, B. A., Brown, K. M., Stone, J. P., Dewkett, D., & Birge, S. J. (2007) · JAMA · doi:10.1001/jama.298.4.413 · Cited by 163
A generalized Dunnett test for multi-arm multi-stage clinical studies with treatment selection
Magirr, D., Jaki, T., & Whitehead, J. (2012) · Biometrika · doi:10.1093/biomet/ass002 · Cited by 162
A randomised clinical trial of two docetaxel regimens (weekly vs 3 week) in the second-line treatment of non-small-cell lung cancer. The DISTAL 01 study
on behalf of the DISTAL (Docetaxel In Second-line Treatment of Advanced Lung cancer) Investigators, Gridelli, C., Gallo, C., Maïo, M. D., Barletta, E., Illiano, A., Maione, P., Salvagni, S., Piantedosi, F. V., Palazzolo, G., et al. (2004) · British Journal of Cancer · doi:10.1038/sj.bjc.6602241 · Cited by 162
Fetal Pulse Oximetry and Cesarean Delivery
Bloom, S. L., Spong, C. Y., Thom, E. A., Varner, M. W., Rouse, D. J., Weininger, S., Ramin, S. M., Caritis, S. N., Peaceman, A. M., Sorokin, Y., et al. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa061170 · Cited by 161
Topotecan Compared With No Therapy After Response to Surgery and Carboplatin/Paclitaxel in Patients With Ovarian Cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) Randomized Study
Placido, S. D., Scambia, G., Vagno, G. D., Naglieri, E., Lombardi, A. V., Biamonte, R., Marinaccio, M., Cartenì, G., Manzione, L., Febbraro, A., et al. (2004) · Journal of Clinical Oncology · doi:10.1200/jco.2004.09.088 · Cited by 161
Treatment of (“bulky”) stage IB cervical cancer with or without neoadjuvant vincristine and cisplatin prior to radical hysterectomy and pelvic/para-aortic lymphadenectomy: A phase III trial of the gynecologic oncology group
Eddy, G. L., Bundy, B. N., Creasman, W. T., Spirtos, N. M., Mannel, R. S., Hannigan, E. V., & O’Connor, D. (2007) · Gynecologic Oncology · doi:10.1016/j.ygyno.2007.04.007 · Cited by 160
Practical problems in interim analyses, with particular regard to estimation
Pocock, S., & Hughes, M. D. (1989) · Controlled Clinical Trials · doi:10.1016/0197-2456(89)90059-7 · Cited by 160
Surgery for subfoveal choroidal neovascularization in age-related macular degeneration: Ophthalmic findings
Hawkins, B. S., Bressler, N. M., Miskala, P. H., Bressler, S. B., Holekamp, N. M., Marsh, M. J., Redford, M., Schwartz, S. D., Sternberg, P., Thomas, M. A., et al. (2004) · Ophthalmology · doi:10.1016/j.ophtha.2004.07.021 · Cited by 157
17 alpha-hydroxyprogesterone caproate to prevent prematurity in nulliparas with cervical length less than 30 mm
Grobman, W. A., Thom, E. A., Spong, C. Y., Iams, J. D., Saade, G. R., Mercer, B. M., Tita, A., Rouse, D. J., Sorokin, Y., Wapner, R. J., et al. (2012) · American Journal of Obstetrics and Gynecology · doi:10.1016/j.ajog.2012.09.013 · Cited by 158
A Trial of Hyperimmune Globulin to Prevent Congenital Cytomegalovirus Infection
Hughes, B. L., Clifton, R. G., Rouse, D. J., Saade, G. R., Dinsmoor, M. J., Reddy, U. M., Pass, R. F., Allard, D. M., Mallett, G. L., Fette, L. M., et al. (2021) · New England Journal of Medicine · doi:10.1056/nejmoa1913569 · Cited by 157
Zidovudine, Didanosine, or Both as the Initial Treatment for Symptomatic HIV-Infected Children
Englund, J. A., Baker, C. J., Raskino, C., McKinney, R. E., Petrie, B., Fowler, M. G., Pearson, D. A., Gershon, A. A., McSherry, G., Abrams, E. J., et al. (1997) · New England Journal of Medicine · doi:10.1056/nejm199706123362403 · Cited by 156

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

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 ›

Are you an author, or do you see a problem with this page? Request a review

Discrete sequential boundaries for clinical trials

Abstract

Overview

Integrity signals

Verification

Claims the paper makes

Claims other papers make about this one

Citations

Cites

Cited by

Related

Metadata

Record

About these checks