Approximately Optimal One-Parameter Boundaries for Group Sequential Trials
Abstract
We present a class of group sequential tests, indexed by a single parameter, that yields approximately optimal results. We also provide tables of key values to help in the design of group sequential tests that meet selected specifications.
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The interim analysis on patients who achieved stable remission did not show superiority of esketamine and antidepressant over antidepressant and placebo; the study continued, and the number of relapses was reestimated to 59 with an adjusted significance level of .046, ensuring conditional power of 90% or higher after the interim analysis.
“The interim analysis on patients who achieved stable remission did not show superiority of esketamine and antidepressant over antidepressant and placebo (at a 2-sided significance level of .0097,log-rank test); therefore, the study continued, and the number of relapses in patients who achieved stable remission was reestimated to 59 relapses in total with an adjusted significance level of .046(2-s”
Cites
A Multiple Testing Procedure for Clinical Trials
O'Brien, P. C., & Fleming, T. R. (1979) · Biometrics · doi:10.2307/2530245 · Cited by 3,311 · see citing works
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 · see citing works
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 776 · see citing works
Interim Analyses for Randomized Clinical Trials: The Group Sequential Approach
Pocock, S. (1982) · Biometrics · doi:10.2307/2530298 · Cited by 265 · see citing works
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Stummer, W., Pichlmeier, U., Meinel, T., Wiestler, O. D., Zanella, F., & Reulen, H.-J. (2006) · The Lancet Oncology · doi:10.1016/s1470-2045(06)70665-9 · Cited by 3,423 · see citing works
Cardiac-Resynchronization Therapy for the Prevention of Heart-Failure Events
Moss, A. J., Hall, W. J., Cannom, D. S., Klein, H., Brown, M. W., Daubert, J. P., Estes, N. A. M., Foster, E., Greenberg, H., Higgins, S. L., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0906431 · Cited by 3,157 · see citing works
Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions
The FUTURE II Study Group (2007) · New England Journal of Medicine · doi:10.1056/nejmoa061741 · Cited by 2,056 · see citing works
Lämmer, J., Malagari, K., Vogl, T. J., Pilleul, F., Denys, A. L., Watkinson, A. F., Pitton, M. B., Sergent, G., Pfammatter, T., Terraz, S., et al. (2009) · CardioVascular and Interventional Radiology · doi:10.1007/s00270-009-9711-7 · Cited by 1,553 · see citing works
Paavonen, J. A., Jenkins, D., Bosch, F. X., Naud, P., Salmerón, J., Wheeler, C. M., Chow, S., Apter, D. L., Kitchener, H. C., Castellsagué, X., et al. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60946-5 · Cited by 1,313 · see citing works
Bretz, F., Hothorn, T., & Westfall, P. (2016) · doi:10.1201/9781420010909 · Cited by 1,233 · see citing works
Daly, E. J., Trivedi, M. H., Janik, A., Li, H., Zhang, Y., Li, X., Lane, R., Lim, P., Duca, A. R., Hough, D., et al. (2019) · JAMA Psychiatry · doi:10.1001/jamapsychiatry.2019.1189 · Cited by 795 · see citing works
Group Sequential Methods with Applications to Clinical Trials
Kim, K. (2001) · Controlled Clinical Trials · doi:10.1016/s0197-2456(00)00127-6 · Cited by 705 · see citing works
Adaptive Sample Size Calculations in Group Sequential Trials
Lehmacher, W., & Wassmer, G. (1999) · Biometrics · doi:10.1111/j.0006-341x.1999.01286.x · Cited by 599 · see citing works
Sequential Changepoint Detection in Quality Control and Dynamical Systems
Lai, T. L. (1995) · Journal of the Royal Statistical Society Series B (Statistical Methodology) · doi:10.1111/j.2517-6161.1995.tb02052.x · Cited by 581 · see citing works
Sirolimus and Kidney Growth in Autosomal Dominant Polycystic Kidney Disease
Serra, A. L., Poster, D., Kistler, A. D., Krauer, F., Raina, S., Young, J., Rentsch, K., Spanaus, K. S., Senn, O., Kristanto, P., et al. (2010) · New England Journal of Medicine · doi:10.1056/nejmoa0907419 · Cited by 572 · see citing works
Demetri, G. D., Chawla, S. P., von Mehren, M., Ritch, P. S., Baker, L. H., Blay, J., Hande, K. R., Keohan, M. L., Samuels, B. L., Schuetze, S. M., et al. (2009) · Journal of Clinical Oncology · doi:10.1200/jco.2008.21.0088 · Cited by 537 · see citing works
Adaptive design methods in clinical trials–a review
Chow, S.-C., & Chang, M. (2008) · Orphanet Journal of Rare Diseases · doi:10.1186/1750-1172-3-11 · Cited by 482 · see citing works
An introduction to multiplicity issues in clinical trials: the what, why, when and how
Li, G., Taljaard, M., Van den Heuvel, E. R., Levine, M. A., Cook, D. J., Wells, G. A., Devereaux, P. J., & Thabane, L. (2016) · International Journal of Epidemiology · doi:10.1093/ije/dyw320 · Cited by 381 · see citing works
Müller, H., & Schäfer, H. (2001) · Biometrics · doi:10.1111/j.0006-341x.2001.00886.x · Cited by 374 · see citing works
Out-of-Hospital Hypertonic Resuscitation Following Severe Traumatic Brain Injury
Bulger, E. M., May, S. J., Brasel, K. J., Schreiber, M. A., Kerby, J. D., Tisherman, S. A., Newgard, C. D., Slutsky, A. S., Coimbra, R. S. M., Emerson, S. S., et al. (2010) · JAMA · doi:10.1001/jama.2010.1405 · Cited by 305 · see citing works
Effect of Dipyridamole plus Aspirin on Hemodialysis Graft Patency
Dixon, B. S., Beck, G. J., Vázquez, M. A., Greenberg, A., Delmez, J. A., Allon, M., Dember, L. M., Himmelfarb, J., Gassman, J., Greene, T., et al. (2009) · New England Journal of Medicine · doi:10.1056/nejmoa0805840 · Cited by 290 · see citing works
Out-of-hospital Hypertonic Resuscitation After Traumatic Hypovolemic Shock
Bulger, E. M., May, S. J., Kerby, J. D., Emerson, S. S., Stiell, I. G., Schreiber, M. A., Brasel, K. J., Tisherman, S. A., Coimbra, R. S. M., Rizoli, S. B., et al. (2010) · Annals of Surgery · doi:10.1097/sla.0b013e3181fcdb22 · Cited by 283 · see citing works
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 · see citing works
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 · see citing works
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 · see citing works
Moss, A. J., Brown, M. W., Cannom, D. S., Daubert, J. P., Estes, M., Foster, E., Greenberg, H., Hall, W. J., Higgins, S. L., Klein, H., et al. (2005) · Annals of Noninvasive Electrocardiology · doi:10.1111/j.1542-474x.2005.00073.x · Cited by 226 · see citing works
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 · see citing works
Pampallona, S., & Tsiatis, A. A. (1994) · Journal of Statistical Planning and Inference · doi:10.1016/0378-3758(94)90187-2 · Cited by 219 · see citing works
Self-citationSequential boundaries approach in clinical trials with unequal allocation ratios
Jafari, P., Ayatollahi, S. M. T., & Behboodian, J. (2006) · BMC Medical Research Methodology · doi:10.1186/1471-2288-6-1 · Cited by 217 · see citing works
Kruis, W., Kiudelis, G., Rácz, I. A., Gorelov, I. A., Pokrotnieks, J., Horyński, M., Bátovský, M., Kykal, J., Boehm, S. A., Greinwald, R., et al. (2008) · Gut · doi:10.1136/gut.2008.154302 · Cited by 204 · see citing works
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 · see citing works
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 · see citing works
Stadtmauer, E. A., Sullivan, K. M., Marty, F. M., Dadwal, S., Papanicolaou, G. A., Shea, T. C., Mossad, S. B., Andreadis, C. B., Young, J. H., Buadi, F. K., et al. (2014) · Blood · doi:10.1182/blood-2014-04-573048 · Cited by 179 · see citing works
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 · see citing works
Self-citationHYPERTONIC RESUSCITATION OF HYPOVOLEMIC SHOCK AFTER BLUNT TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Bulger, E. M., Jurkovich, G. J., Nathens, A., Copass, M., Hanson, S., Cooper, C., Liu, P., Neff, M., Awan, A. B., Warner, K. J., et al. (2006) · Archives of Surgery · doi:10.1001/archsurg.2007.41 · Cited by 159 · see citing works
Adaptive Design Methods in Clinical Trials
Chow, S., & Pong, A. (2010) · Informa Healthcare eBooks · doi:10.3109/9781439822463.003 · Cited by 165 · see citing works
Austerity in MCMC Land: Cutting the Metropolis-Hastings Budget
Korattikara, A., Chen, Y., & Welling, M. (2013) · UvA-DARE (University of Amsterdam) · doi:10.48550/arxiv.1304.5299 · Cited by 155 · see citing works
A general statistical principle for changing a design any time during the course of a trial
Müller, H., & Schäfer, H. (2004) · Statistics in Medicine · doi:10.1002/sim.1852 · Cited by 152 · see citing works
Dupuis, L., Dengler, R., Heneka, M. T., Meyer, T., Zierz, S., Kassubek, J., Fischer, W., Steiner, F., Lindauer, E., Otto, M., et al. (2012) · PLoS ONE · doi:10.1371/journal.pone.0037885 · Cited by 151 · see citing works
Symmetric Group Sequential Test Designs
Emerson, S. S., & Fleming, T. R. (1989) · Biometrics · doi:10.2307/2531692 · Cited by 141 · see citing works
Carde, P. P., Karrasch, M., Fortpied, C., Brice, P., Khaled, H. M., Casasnovas, O., Caillot, D., Gaillard, I., Bologna, S., Fermé, C., et al. (2016) · Journal of Clinical Oncology · doi:10.1200/jco.2015.64.5648 · Cited by 122 · see citing works
Sample size re‐estimation: recent developments and practical considerations
Gould, A. L. (2001) · Statistics in Medicine · doi:10.1002/sim.733 · Cited by 115 · see citing works
Some recommendations for multi-arm multi-stage trials
Wason, J. M. S., Magirr, D., Law, M. W.-M., & Jaki, T. (2012) · Statistical Methods in Medical Research · doi:10.1177/0962280212465498 · Cited by 113 · see citing works
Issues in designing flexible trials
Posch, M., Bauer, P., & Brannath, W. (2003) · Statistics in Medicine · doi:10.1002/sim.1455 · Cited by 109 · see citing works
An Improved Method for Deriving Optimal One-Sided Group Sequential Tests
Eales, J. D., & Jennison, C. (1992) · Biometrika · doi:10.1093/biomet/79.1.13 · Cited by 107 · see citing works
Adaptive design clinical trials: Methodology, challenges and prospect
Mahajan, R., & Gupta, K. (2010) · Indian Journal of Pharmacology · doi:10.4103/0253-7613.68417 · Cited by 104 · see citing works
Planning and Analyzing Adaptive Group Sequential Survival Trials
Wassmer, G. (2006) · Biometrical Journal · doi:10.1002/bimj.200510190 · Cited by 101 · see citing works
A Unifying Family of Group Sequential Test Designs
Kittelson, J. M., & Emerson, S. S. (1999) · Biometrics · doi:10.1111/j.0006-341x.1999.00874.x · Cited by 98 · see citing works
Flexible Sample Size Considerations Using Information-Based Interim Monitoring
Mehta, C. R., & Tsiatis, A. A. (2001) · Drug Information Journal · doi:10.1177/009286150103500407 · Cited by 94 · see citing works
Self-citationFrequentist evaluation of group sequential clinical trial designs
Emerson, S. S., Kittelson, J. M., & Gillen, D. L. (2007) · Statistics in Medicine · doi:10.1002/sim.2901 · Cited by 87 · see citing works
A formal test of the hypothesis that idiopathic calcium oxalate stones grow on Randall’s plaque
Miller, N. L., Gillen, D. L., Williams, J. C., Evan, A. P., Bledsoe, S. B., Coe, F. L., Worcester, E. M., Matlaga, B. R., Munch, L. C., & Lingeman, J. E. (2008) · British Journal of Urology · doi:10.1111/j.1464-410x.2008.08193.x · Cited by 84 · see citing works
Kaizer, A. M., Belli, H. M., Ma, Z., Nicklawsky, A., Roberts, S. C., Wild, J. L., Wogu, A. F., Xiao, M., & Sabo, R. T. (2023) · Journal of Clinical and Translational Science · doi:10.1017/cts.2023.537 · Cited by 81 · see citing works
Testing a Primary and a Secondary Endpoint in a Group Sequential Design
Tamhane, A. C., Mehta, C. R., & Liu, L. (2010) · Biometrics · doi:10.1111/j.1541-0420.2010.01402.x · Cited by 68 · see citing works
Pampallona, S., Tsiatis, A. A., & Kim, K. (2001) · Drug Information Journal · doi:10.1177/009286150103500408 · Cited by 67 · see citing works
Self-citationMatthys, H., & Heger, M. (2007) · Current Medical Research and Opinion · doi:10.1185/030079906x167318 · Cited by 65 · see citing works
Power, sample size and adaptation considerations in the design of group sequential clinical trials
Lai, T. L., & Shih, M. (2004) · Biometrika · doi:10.1093/biomet/91.3.507 · Cited by 62 · see citing works
A decade of progress in statistical methodology for clinical trials
Simon, R. M. (1991) · Statistics in Medicine · doi:10.1002/sim.4780101203 · Cited by 61 · see citing works
Stevely, A. K., Dimairo, M., Todd, S., Julious, S. A., Nicholl, J. P., Hind, D., & Cooper, C. L. (2015) · PLoS ONE · doi:10.1371/journal.pone.0141104 · Cited by 58 · see citing works
A comment on futility monitoring
Freidlin, B., & Korn, E. L. (2002) · Controlled Clinical Trials · doi:10.1016/s0197-2456(02)00218-0 · Cited by 57 · see citing works
Serra, A. L., Kistler, A. D., Poster, D., Struker, M., Wuthrich, R. P., Weishaupt, D., & Tschirch, F. T. C. (2007) · BMC Nephrology · doi:10.1186/1471-2369-8-13 · Cited by 57 · see citing works
Nelson, J. C., Cook, A. J., Yu, O., Dominguez, C., Zhao, S., Greene, S. K., FIREMAN, B. H., Jacobsen, S. J., Weintraub, E., & Jackson, L. A. (2012) · Pharmacoepidemiology and Drug Safety · doi:10.1002/pds.2324 · Cited by 55 · see citing works
Interim analyses and sequential designs in phase III studies
Todd, S., Whitehead, A., Stallard, N., & Whitehead, J. (2001) · British Journal of Clinical Pharmacology · doi:10.1046/j.1365-2125.2001.01382.x · Cited by 53 · see citing works
Schnabel, D., Grasemann, C., Staab, D., Wollmann, H. A., Ratjen, F. A., & for the German Cystic Fibrosis Growth Hormone Study Group (2007) · PEDIATRICS · doi:10.1542/peds.2006-2783 · Cited by 51 · see citing works
Interim futility analysis with intermediate endpoints
Goldman, B. H., LeBlanc, M. L., & Crowley, J. J. (2008) · Clinical Trials · doi:10.1177/1740774507086648 · Cited by 51 · see citing works
Viscoli, C. M., Brass, L. M., Carolei, A., Conwit, R., Ford, G. A., Furie, K. L., Gorman, M., Guarino, P. D., Inzucchi, S. E., Lovejoy, A. M., et al. (2014) · American Heart Journal · doi:10.1016/j.ahj.2014.07.016 · Cited by 50 · see citing works
Ertelt, D., Hemmelmann, C., Dettmers, C., Ziegler, A., & Binkofski, F. (2012) · BMC Neurology · doi:10.1186/1471-2377-12-42 · Cited by 50 · see citing works
A group sequential Holm procedure with multiple primary endpoints
Ye, Y., Li, A., Liu, L., & Yao, B. (2012) · Statistics in Medicine · doi:10.1002/sim.5700 · Cited by 48 · see citing works
Exact Confidence Bounds Following Adaptive Group Sequential Tests
Brannath, W., Mehta, C. R., & Posch, M. (2008) · Biometrics · doi:10.1111/j.1541-0420.2008.01101.x · Cited by 48 · see citing works
Repeated confidence intervals for adaptive group sequential trials
Mehta, C. R., Bauer, P., Posch, M., & Brannath, W. (2007) · Statistics in Medicine · doi:10.1002/sim.3062 · Cited by 45 · see citing works
Application of the triangular test to phase II cancer clinical trials
Bellissant, É., Bénichou, J., & Chastang, C. (1990) · Statistics in Medicine · doi:10.1002/sim.4780090807 · Cited by 45 · see citing works
Rui, Q., Wang, Y., Shu, L., Liu, Y., Wu, Y., Wu, Q., Nuamah, I. F., & Gopal, S. (2014) · Progress in Neuro-Psychopharmacology and Biological Psychiatry · doi:10.1016/j.pnpbp.2014.02.007 · Cited by 44 · see citing works
A Brief Review on Software Developments for Group Sequential and Adaptive Designs
Wassmer, G., & Vandemeulebroecke, M. (2006) · Biometrical Journal · doi:10.1002/bimj.200510233 · Cited by 43 · see citing works
Adaptive clinical trial designs in oncology.
Zang, Y., & Lee, J. J. (2014) · PubMed · doi:10.3978/j.issn.2304-3865.2014.06.04 · Cited by 42 · see citing works
Nelson, J. C., Yu, O., Domínguez‐Islas, C., Cook, A. J., Peterson, D., Greene, S. K., Yih, W. K., Daley, M. F., Jacobsen, S. J., Klein, N. P., et al. (2013) · American Journal of Epidemiology · doi:10.1093/aje/kws317 · Cited by 41 · see citing works
Pritchett, Y., Menon, S., Marchenko, O., Antonijevic, Z., Miller, E. R., Sanchez‐Kam, M., Morgan-Bouniol, C. C., Nguyen, H., & Prucka, W. R. (2015) · Statistics in Biopharmaceutical Research · doi:10.1080/19466315.2015.1098564 · Cited by 41 · see citing works
Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier
Rigo, J., Hascoët, J., Billeaud, C., Picaud, J., Mosca, F., Rubio, A., Saliba, É., Radke, M. H., Siméoni, U., Guillois, B., et al. (2017) · Journal of Pediatric Gastroenterology and Nutrition · doi:10.1097/mpg.0000000000001686 · Cited by 41 · see citing works
Desch, S., Freund, A., Graf, T., Fichtlscherer, S., Haake, H., Preusch, M. R., Hammer, F., Akın, İ., Christ, M., Liebetrau, C., et al. (2018) · American Heart Journal · doi:10.1016/j.ahj.2018.12.005 · Cited by 41 · see citing works
Optimal two-sided group sequential tests
Eales, J. D. (1995) · Sequential Analysis · doi:10.1080/07474949508836337 · Cited by 40 · see citing works
Glotzer, T. V., Daoud, E. G., Wyse, D. G., Singer, D. E., Holbrook, R., Pruett, K., Smith, K., & Hilker, C. E. (2006) · Journal of Interventional Cardiac Electrophysiology · doi:10.1007/s10840-006-7622-y · Cited by 40 · see citing works
Optimal Conditional Error Functions for the Control of Conditional Power
Brannath, W., & Bauer, P. (2004) · Biometrics · doi:10.1111/j.0006-341x.2004.00221.x · Cited by 38 · see citing works
Eliakim, R., Tulassay, Z., Kupčinskas, L., Adamonis, K., Pokrotnieks, J., Bar–Meir, S., Lavy, A., Müeller, R., Greinwald, R., Chermesh, I., et al. (2007) · Alimentary Pharmacology & Therapeutics · doi:10.1111/j.1365-2036.2007.03468.x · Cited by 37 · see citing works
Group Sequential and Adaptive Designs – A Review of Basic Concepts and Points of Discussion
Vandemeulebroecke, M. (2008) · Biometrical Journal · doi:10.1002/bimj.200710436 · Cited by 36 · see citing works
Interim monitoring of clinical trials based on long-term binary endpoints
Marschner, I. C., & Becker, S. L. (2001) · Statistics in Medicine · doi:10.1002/1097-0258(20010130)20:2 · Cited by 36 · see citing works
Vollert, B., Beintner, I., Musiat, P., Gordon, G., Görlich, D., Nacke, B., Schmidt-Hantke, J., Potterton, R., Spencer, L., Grant, N., et al. (2018) · Internet Interventions · doi:10.1016/j.invent.2018.02.010 · Cited by 35 · see citing works
Sequential methods and group sequential designs for comparative clinical trials
Sebille, V., & Bellissant, É. (2003) · Fundamental and Clinical Pharmacology · doi:10.1046/j.1472-8206.2003.00192.x · Cited by 35 · see citing works
Jones, M., Zeiler, M. D., Herrero, R., Kuso, S., Nitsch, M., Etchemendy, E., Fonseca-Baeza, S., Oliver, E., Adamcik, T., Karwautz, A. F. K., et al. (2018) · Internet Interventions · doi:10.1016/j.invent.2018.02.007 · Cited by 34 · see citing works
Repeated significance testing in longitudinal clinical trials
Lee, S. J. (1996) · Biometrika · doi:10.1093/biomet/83.4.779 · Cited by 34 · see citing works
Issues in the use of adaptive clinical trial designs
Emerson, S. S. (2006) · Statistics in Medicine · doi:10.1002/sim.2626 · Cited by 34 · see citing works
Early Stopping to Accept H 0 Based on Conditional Power: Approximations and Comparisons
Betensky, R. A. (1997) · Biometrics · doi:10.2307/2533543 · Cited by 34 · see citing works
Information-based monitoring of clinical trials
Tsiatis, A. A. (2006) · Statistics in Medicine · doi:10.1002/sim.2625 · Cited by 33 · see citing works
Self-citationGroup Sequential Designs: A TutorialPreprint
Lakens, D., Pahlke, F., & Wassmer, G. (2021) · doi:10.31234/osf.io/x4azm · Cited by 36 · see citing works
Bayesian adaptive model selection for optimizing group sequential clinical trials
Wathen, J. K., & Thall, P. F. (2008) · Statistics in Medicine · doi:10.1002/sim.3381 · Cited by 31 · see citing works
Design of the Dialysis Access Consortium (DAC) Aggrenox prevention of access stenosis trial
Dixon, B. S., Beck, G. J., Dember, L. M., Depner, T. A., Gassman, J., Greene, T., Himmelfar, J., Hunsicker, L. G., Kaufman, J. S., Lawson, J. H., et al. (2005) · Clinical Trials · doi:10.1191/1740774505cn110oa · Cited by 31 · see citing works
Control of Type I Error Rates in Bayesian Sequential Designs
Shi, H., & Yin, G. (2018) · Bayesian Analysis · doi:10.1214/18-ba1109 · Cited by 30 · see citing works
Two‐stage designs for cross‐over bioequivalence trials
Kieser, M., & Rauch, G. (2015) · Statistics in Medicine · doi:10.1002/sim.6487 · Cited by 30 · see citing works
Group sequential testing in clinical trials with multivariate observations: A review
Lee, J. W. (1994) · Statistics in Medicine · doi:10.1002/sim.4780130202 · Cited by 30 · see citing works
Basic concepts of group sequential and adaptive group sequential test procedures
Wassmer, G. (2000) · Statistical Papers · doi:10.1007/bf02925923 · Cited by 30 · see citing works
Moore, E. E., Johnson, J. L., Moore, F. A., & Moore, H. B. (2009) · Critical Care Clinics · doi:10.1016/j.ccc.2009.01.002 · Cited by 29 · see citing works
Data Monitoring in Clinical Trials Using Prediction
Evans, S. R., Li, L., & Wei, L. J. (2007) · Drug Information Journal · doi:10.1177/009286150704100606 · Cited by 28 · see citing works
Emerson, S. S., & Kittelson, J. M. (1997) · Biometrics · doi:10.2307/2533122 · Cited by 28 · see citing works
Flexible Interim Analyses in Clinical Trials Using Multistage Adaptive Test Designs
Wassmer, G., Eisebitt, R., & Coburger, S. (2001) · Drug Information Journal · doi:10.1177/009286150103500410 · Cited by 28 · see citing works
An investigation of the impact of futility analysis in publicly funded trials
Sully, B., Julious, S. A., & Nicholl, J. P. (2014) · Trials · doi:10.1186/1745-6215-15-61 · Cited by 27 · see citing works
Adaptive Clinical Trial Designs with Surrogates: When Should We Bother?
Anderer, A., Bastani, H., & Silberholz, J. (2019) · Management Science · doi:10.1287/mnsc.2021.4096 · Cited by 28 · see citing works
Optimal two‐stage designs for clinical trials based on safety and efficacy
Thall, P. F., & Cheng, S. (2001) · Statistics in Medicine · doi:10.1002/sim.717 · Cited by 27 · see citing works
- Authors
- Wang, S. K., & Tsiatis, A. A.
- Venue
- Biometrics
- Publisher
- JSTOR
- Published
- 1987-03
- Volume
- 43
- Issue
- 1
- Pages
- 193
- ISSN
- 0006-341X (ISSN-L)
- OpenAlex
- W2090824711
- Cited by
- 341
- References
- 4
- Citations by year
- 2026: 6 · 2025: 9 · 2024: 10 · 2023: 8 · 2022: 7 · 2021: 11 · 2020: 8 · 2019: 10 · 2018: 13 · 2017: 5 · 2016: 13 · 2015: 9 · 2014: 20 · 2013: 8 · 2012: 25
- FWCI
- 4.23
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Biometrics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Cancer Institute (CA23415, CA-35446)
- 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
- group sequential tests, approximate optimality, clinical trial design, stopping boundaries
- MeSH terms
- Clinical Trials as Topic, Humans, Statistics as Topic
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