References

All works cited in this tutorial.

DOIs and bibliographic details were taken from CrossRef. Each page also lists its own references at the bottom.

2006. In Statistics for Biology and Health. Springer New York. https://doi.org/10.1007/978-0-387-44970-8.

Anderson, Keaven M., and Jason B. Clark. 2010. “Fitting Spending Functions.” Statistics in Medicine 29 (3): 321–27. https://doi.org/10.1002/sim.3737.

Armitage, P. 1957. “Restricted Sequential Procedures.” Biometrika 44 (1/2): 9. https://doi.org/10.2307/2333237.

Armitage, P., C. K. McPherson, and B. C. Rowe. 1969. “Repeated Significance Tests on Accumulating Data.” Journal of the Royal Statistical Society. Series A (General) 132 (2): 235. https://doi.org/10.2307/2343787.

Bassler, Dirk, Matthias Briel, Victor M. Montori, et al. 2010. “Stopping Randomized Trials Early for Benefit and Estimation of Treatment Effects: Systematic Review and Meta-Regression Analysis.” JAMA 303 (12): 1180. https://doi.org/10.1001/jama.2010.310.

Bauer, P., and K. Kohne. 1994. “Evaluation of Experiments with Adaptive Interim Analyses.” Biometrics 50 (4): 1029. https://doi.org/10.2307/2533441.

Berry, Donald A. 2006. “Bayesian Clinical Trials.” Nature Reviews Drug Discovery 5 (1): 27–36. https://doi.org/10.1038/nrd1927.

Bretz, Frank, Franz Koenig, Werner Brannath, Ekkehard Glimm, and Martin Posch. 2009. “Adaptive Designs for Confirmatory Clinical Trials.” Statistics in Medicine 28 (8): 1181–217. https://doi.org/10.1002/sim.3538.

Brookes, Sara T., Elise Whitely, Matthias Egger, George Davey Smith, Paul A. Mulheran, and Tim J. Peters. 2004. “Subgroup Analyses in Randomized Trials: Risks of Subgroup-Specific Analyses;” Journal of Clinical Epidemiology 57 (3): 229–36. https://doi.org/10.1016/j.jclinepi.2003.08.009.

Bryant, John, and Roger Day. 1995. “Incorporating Toxicity Considerations into the Design of Two-Stage Phase II Clinical Trials.” Biometrics 51 (4): 1372. https://doi.org/10.2307/2533268.

Burnett, Thomas, and Christopher Jennison. 2020. “Adaptive Enrichment Trials: What Are the Benefits?” Statistics in Medicine 40 (3): 690–711. https://doi.org/10.1002/sim.8797.

Burnett, Thomas, Pavel Mozgunov, Philip Pallmann, Sofia S. Villar, Graham M. Wheeler, and Thomas Jaki. 2020. “Adding Flexibility to Clinical Trial Designs: An Example-Based Guide to the Practical Use of Adaptive Designs.” BMC Medicine 18 (1). https://doi.org/10.1186/s12916-020-01808-2.

Cui, Lu, H. M. James Hung, and Sue‐Jane Wang. 1999. “Modification of Sample Size in Group Sequential Clinical Trials.” Biometrics 55 (3): 853–57. https://doi.org/10.1111/j.0006-341x.1999.00853.x.

DeMets, David L., and Susan S. Ellenberg. 2016. “Data Monitoring Committees — Expect the Unexpected.” New England Journal of Medicine 375 (14): 1365–71. https://doi.org/10.1056/nejmra1510066.

DeMets, David L., and K. K. Gordon Lan. 1994. “Interim Analysis: The Alpha Spending Function Approach.” Statistics in Medicine 13 (13-14): 1341–52. https://doi.org/10.1002/sim.4780131308.

Dimairo, Munyaradzi, Philip Pallmann, James Wason, et al. 2020. “The Adaptive Designs CONSORT Extension (ACE) Statement: A Checklist with Explanation and Elaboration Guideline for Reporting Randomised Trials That Use an Adaptive Design.” BMJ, m115. https://doi.org/10.1136/bmj.m115.

Emerson, Scott S., and Thomas R. Fleming. 1990. “Parameter Estimation Following Group Sequential Hypothesis Testing.” Biometrika 77 (4): 875–92. https://doi.org/10.1093/biomet/77.4.875.

Emerson, Scott S., John M. Kittelson, and Daniel L. Gillen. 2007. “Frequentist Evaluation of Group Sequential Clinical Trial Designs.” Statistics in Medicine 26 (28): 5047–80. https://doi.org/10.1002/sim.2901.

European Medicines Agency, CHMP. 2007. Reflection Paper on Methodological Issues in Confirmatory Clinical Trials Planned with an Adaptive Design (CHMP/EWP/2459/02).

Fairbanks, Kenneth, and Richard Madsen. 1982. “P Values for Tests Using a Repeated Significance Test Design.” Biometrika 69 (1): 69–74. https://doi.org/10.1093/biomet/69.1.69.

Fleming, Thomas R. 1982. “One-Sample Multiple Testing Procedure for Phase II Clinical Trials.” Biometrics 38 (1): 143. https://doi.org/10.2307/2530297.

Freedman, L. S. 1982. “Tables of the Number of Patients Required in Clinical Trials Using the Logrank Test.” Statistics in Medicine 1 (2): 121–29. https://doi.org/10.1002/sim.4780010204.

Freidlin, Boris, and Edward L. Korn. 2013. “Biomarker Enrichment Strategies: Matching Trial Design to Biomarker Credentials.” Nature Reviews Clinical Oncology 11 (2): 81–90. https://doi.org/10.1038/nrclinonc.2013.218.

Freidlin, Boris, Lisa M. McShane, Mei-Yin C. Polley, and Edward L. Korn. 2012. “Randomized Phase II Trial Designs with Biomarkers.” Journal of Clinical Oncology 30 (26): 3304–9. https://doi.org/10.1200/jco.2012.43.3946.

Friede, Tim, and Meinhard Kieser. 2006. “Sample Size Recalculation in Internal Pilot Study Designs: A Review.” Biometrical Journal 48 (4): 537–55. https://doi.org/10.1002/bimj.200510238.

Gail, M., and R. Simon. 1985. “Testing for Qualitative Interactions Between Treatment Effects and Patient Subsets.” Biometrics 41 (2): 361. https://doi.org/10.2307/2530862.

Gehan, Edmund A. 1961. “The Determination of the Number of Patients Required in a Preliminary and a Follow-up Trial of a New Chemotherapeutic Agent.” Journal of Chronic Diseases 13 (4): 346–53. https://doi.org/10.1016/0021-9681(61)90060-1.

Genz, Alan. 2004. “Numerical Computation of Rectangular Bivariate and Trivariate Normal and t Probabilities.” Statistics and Computing 14 (3): 251–60. https://doi.org/10.1023/b:stco.0000035304.20635.31.

Gordon Lan, K. K., Richard Simon, and Max Halperin. 1982. “Stochastically Curtailed Tests in Long–Term Clinical Trials.” Communications in Statistics. Part C: Sequential Analysis 1 (3): 207–19. https://doi.org/10.1080/07474948208836014.

Grayling, Michael John, and Graham Mark Wheeler. 2020. “A Review of Available Software for Adaptive Clinical Trial Design.” Clinical Trials 17 (3): 323–31. https://doi.org/10.1177/1740774520906398.

Grigg, O., and V. Farewell. 2004. “An Overview of Risk-Adjusted Charts.” Journal of the Royal Statistical Society Series A: Statistics in Society 167 (3): 523–39. https://doi.org/10.1111/j.1467-985x.2004.0apm2.x.

Grünwald, Peter, Rianne de Heide, and Wouter Koolen. 2024. “Safe Testing.” Journal of the Royal Statistical Society Series B: Statistical Methodology 86 (5): 1091–128. https://doi.org/10.1093/jrsssb/qkae011.

Hajnal, J. 1961. “A Two-Sample Sequential t-Test.” Biometrika 48 (1/2): 65. https://doi.org/10.2307/2333131.

Haybittle, J. L. 1971. “Repeated Assessment of Results in Clinical Trials of Cancer Treatment.” The British Journal of Radiology 44 (526): 793–97. https://doi.org/10.1259/0007-1285-44-526-793.

Howard, Steven R., Aaditya Ramdas, Jon McAuliffe, and Jasjeet Sekhon. 2021. “Time-Uniform, Nonparametric, Nonasymptotic Confidence Sequences.” The Annals of Statistics 49 (2). https://doi.org/10.1214/20-aos1991.

Hwang, Irving K., Weichung J. Shih, and John S. De Cani. 1990. “Group Sequential Designs Using a Family of Type i Error Probability Spending Functions.” Statistics in Medicine 9 (12): 1439–45. https://doi.org/10.1002/sim.4780091207.

International Council for Harmonisation. 1998. ICH E9: Statistical Principles for Clinical Trials.

International Council for Harmonisation. 2025. ICH E20: Adaptive Designs for Clinical Trials. Draft Guideline, Step 2b.

Jennison, Christopher, and Bruce Turnbull. 2000. Group Sequential Methods with Applications to Clinical Trials. In Chapman & Hall/CRC Interdisciplinary Statistics Series. Chapman & Hall/CRC. https://doi.org/10.1201/9781584888581.

Jennison, Christopher, and Bruce W. Turnbull. 1989. “Interim Analyses: The Repeated Confidence Interval Approach.” Journal of the Royal Statistical Society Series B: Statistical Methodology 51 (3): 305–34. https://doi.org/10.1111/j.2517-6161.1989.tb01433.x.

Jennison, Christopher, and Bruce W. Turnbull. 1997. “Group-Sequential Analysis Incorporating Covariate Information.” Journal of the American Statistical Association 92 (440): 1330–41. https://doi.org/10.1080/01621459.1997.10473654.

Jennison, Christopher, and Bruce W. Turnbull. 2006. “Adaptive and Nonadaptive Group Sequential Tests.” Biometrika 93 (1): 1–21. https://doi.org/10.1093/biomet/93.1.1.

Johari, Ramesh, Pete Koomen, Leonid Pekelis, and David Walsh. 2022. “Always Valid Inference: Continuous Monitoring of a/b Tests.” Operations Research 70 (3): 1806–21. https://doi.org/10.1287/opre.2021.2135.

Jones, Cheryl L., and Eric Holmgren. 2007. “An Adaptive Simon Two-Stage Design for Phase 2 Studies of Targeted Therapies.” Contemporary Clinical Trials 28 (5): 654–61. https://doi.org/10.1016/j.cct.2007.02.008.

Jung, Sin‐Ho, Taiyeong Lee, KyungMann Kim, and Stephen L. George. 2004. “Admissible Two‐stage Designs for Phase II Cancer Clinical Trials.” Statistics in Medicine 23 (4): 561–69. https://doi.org/10.1002/sim.1600.

Kim, Kyungmann, and David L. DeMets. 1987. “Design and Analysis of Group Sequential Tests Based on the Type i Error Spending Rate Function.” Biometrika 74 (1): 149–54. https://doi.org/10.1093/biomet/74.1.149.

Kim, Kyungmann, and Anastasios A. Tsiatis. 1990. “Study Duration for Clinical Trials with Survival Response and Early Stopping Rule.” Biometrics 46 (1): 81. https://doi.org/10.2307/2531632.

Kittelson, John M., and Scott S. Emerson. 1999. “A Unifying Family of Group Sequential Test Designs.” Biometrics 55 (3): 874–82. https://doi.org/10.1111/j.0006-341x.1999.00874.x.

Koyama, Tatsuki, and Heidi Chen. 2008. “Proper Inference from Simon’s Two‐stage Designs.” Statistics in Medicine 27 (16): 3145–54. https://doi.org/10.1002/sim.3123.

Kulldorff, Martin, Robert L. Davis, Margarette Kolczak†, Edwin Lewis, Tracy Lieu, and Richard Platt. 2011. “A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance.” Sequential Analysis 30 (1): 58–78. https://doi.org/10.1080/07474946.2011.539924.

Lachin, John M. 2005. “A Review of Methods for Futility Stopping Based on Conditional Power.” Statistics in Medicine 24 (18): 2747–64. https://doi.org/10.1002/sim.2151.

Lachin, John M., and Mary A. Foulkes. 1986. “Evaluation of Sample Size and Power for Analyses of Survival with Allowance for Nonuniform Patient Entry, Losses to Follow-up, Noncompliance, and Stratification.” Biometrics 42 (3): 507. https://doi.org/10.2307/2531201.

Lai, Tze Leung. 2001. “Sequential Analysis: Some Classical Problems and New Challenges.” Statistica Sinica 11: 303–51.

Lakatos, Edward. 1988. “Sample Sizes Based on the Log-Rank Statistic in Complex Clinical Trials.” Biometrics 44 (1): 229. https://doi.org/10.2307/2531910.

Lakens, Daniël. 2014. “Performing High‐powered Studies Efficiently with Sequential Analyses.” European Journal of Social Psychology 44 (7): 701–10. https://doi.org/10.1002/ejsp.2023.

Lakens, Daniel, Friedrich Pahlke, and Gernot Wassmer. 2021. Group Sequential Designs: A Tutorial. January. https://doi.org/10.31234/osf.io/x4azm.

Lan, K. K. Gordon, and David L. DeMets. 1983. “Discrete Sequential Boundaries for Clinical Trials.” Biometrika 70 (3): 659. https://doi.org/10.2307/2336502.

Lan, K. K. Gordon, and David L. DeMets. 1989. “Changing Frequency of Interim Analysis in Sequential Monitoring.” Biometrics 45 (3): 1017. https://doi.org/10.2307/2531701.

Lan, K. K. Gordon, and Janet Wittes. 1988. “The b-Value: A Tool for Monitoring Data.” Biometrics 44 (2): 579. https://doi.org/10.2307/2531870.

Lee, J Jack, and Diane D Liu. 2008. “A Predictive Probability Design for Phase II Cancer Clinical Trials.” Clinical Trials 5 (2): 93–106. https://doi.org/10.1177/1740774508089279.

Lehmacher, Walter, and Gernot Wassmer. 1999. “Adaptive Sample Size Calculations in Group Sequential Trials.” Biometrics 55 (4): 1286–90. https://doi.org/10.1111/j.0006-341x.1999.01286.x.

Leite, Andreia, Nick J. Andrews, and Sara L. Thomas. 2016. “Near Real‐time Vaccine Safety Surveillance Using Electronic Health Records—a Systematic Review of the Application of Statistical Methods.” Pharmacoepidemiology and Drug Safety 25 (3): 225–37. https://doi.org/10.1002/pds.3966.

Li, Lang, and Anastasia Ivanova. 2024. “Isotonic Design for Single-Arm Biomarker Stratified Trials.” Statistical Methods in Medical Research 33 (6): 945–52. https://doi.org/10.1177/09622802241238978.

Magirr, D., T. Jaki, and J. Whitehead. 2012. “A Generalized Dunnett Test for Multi-Arm Multi-Stage Clinical Studies with Treatment Selection.” Biometrika 99 (2): 494–501. https://doi.org/10.1093/biomet/ass002.

McShane, Lisa M., Sally Hunsberger, and Alex A. Adjei. 2009. “Effective Incorporation of Biomarkers into Phase II Trials.” Clinical Cancer Research 15 (6): 1898–905. https://doi.org/10.1158/1078-0432.ccr-08-2033.

Mehta, Cyrus R., and Stuart J. Pocock. 2011. “Adaptive Increase in Sample Size When Interim Results Are Promising: A Practical Guide with Examples.” Statistics in Medicine 30 (28): 3267–84. https://doi.org/10.1002/sim.4102.

Meyer, Elias Laurin, Peter Mesenbrink, Tobias Mielke, Tom Parke, Daniel Evans, and Franz König. 2021. “Systematic Review of Available Software for Multi-Arm Multi-Stage and Platform Clinical Trial Design.” Trials 22 (1). https://doi.org/10.1186/s13063-021-05130-x.

Müller, Hans-Helge, and Helmut Schäfer. 2001. “Adaptive Group Sequential Designs for Clinical Trials: Combining the Advantages of Adaptive and of Classical Group Sequential Approaches.” Biometrics 57 (3): 886–91. https://doi.org/10.1111/j.0006-341x.2001.00886.x.

Nelson, Jennifer C, Andrea J Cook, Onchee Yu, Shanshan Zhao, Lisa A Jackson, and Bruce M Psaty. 2015. “Methods for Observational Post-Licensure Medical Product Safety Surveillance.” Statistical Methods in Medical Research 24 (2): 177–93. https://doi.org/10.1177/0962280211413452.

O’Brien, Peter C., and Thomas R. Fleming. 1979. “A Multiple Testing Procedure for Clinical Trials.” Biometrics 35 (3): 549. https://doi.org/10.2307/2530245.

Page, E. S. 1954. “Continuous Inspection Schemes.” Biometrika 41 (1/2): 100. https://doi.org/10.2307/2333009.

Pallmann, Philip, Alun W. Bedding, Babak Choodari-Oskooei, et al. 2018. “Adaptive Designs in Clinical Trials: Why Use Them, and How to Run and Report Them.” BMC Medicine 16 (1). https://doi.org/10.1186/s12916-018-1017-7.

Pampallona, Sandro, and Anastasios A. Tsiatis. 1994. “Group Sequential Designs for One-Sided and Two-Sided Hypothesis Testing with Provision for Early Stopping in Favor of the Null Hypothesis.” Journal of Statistical Planning and Inference 42 (1-2): 19–35. https://doi.org/10.1016/0378-3758(94)90187-2.

Pampallona, Sandro, Anastasios A. Tsiatis, and Kyungmann Kim. 2001. “Interim Monitoring of Group Sequential Trials Using Spending Functions for the Type i and Type II Error Probabilities.” Drug Information Journal 35 (4): 1113–21. https://doi.org/10.1177/009286150103500408.

Parashar, Deepak, Jack Bowden, Colin Starr, Lorenz Wernisch, and Adrian Mander. 2016. “An Optimal Stratified Simon Two‐stage Design.” Pharmaceutical Statistics 15 (4): 333–40. https://doi.org/10.1002/pst.1742.

Peto, R, M C Pike, P Armitage, et al. 1976. “Design and Analysis of Randomized Clinical Trials Requiring Prolonged Observation of Each Patient. I. Introduction and Design.” British Journal of Cancer 34 (6): 585–612. https://doi.org/10.1038/bjc.1976.220.

Pocock, S. J. 1977. “Group Sequential Methods in the Design and Analysis of Clinical Trials.” Biometrika 64 (2): 191–99. https://doi.org/10.1093/biomet/64.2.191.

Polley, M.-Y. C., B. Freidlin, E. L. Korn, B. A. Conley, J. S. Abrams, and L. M. McShane. 2013. “Statistical and Practical Considerations for Clinical Evaluation of Predictive Biomarkers.” JNCI Journal of the National Cancer Institute 105 (22): 1677–83. https://doi.org/10.1093/jnci/djt282.

Proschan, Michael A., and Sally A. Hunsberger. 1995. “Designed Extension of Studies Based on Conditional Power.” Biometrics 51 (4): 1315. https://doi.org/10.2307/2533262.

Ramdas, Aaditya, Peter Grünwald, Vladimir Vovk, and Glenn Shafer. 2023. “Game-Theoretic Statistics and Safe Anytime-Valid Inference.” Statistical Science 38 (4). https://doi.org/10.1214/23-sts894.

Renfro, Lindsay A., Himel Mallick, Ming-Wen An, Daniel J. Sargent, and Sumithra J. Mandrekar. 2016. “Clinical Trial Designs Incorporating Predictive Biomarkers.” Cancer Treatment Reviews 43 (February): 74–82. https://doi.org/10.1016/j.ctrv.2015.12.008.

Robbins, Herbert. 1970. “Statistical Methods Related to the Law of the Iterated Logarithm.” The Annals of Mathematical Statistics 41 (5): 1397–409. https://doi.org/10.1214/aoms/1177696786.

Robertson, David S., Babak Choodari‐Oskooei, Munya Dimairo, Laura Flight, Philip Pallmann, and Thomas Jaki. 2023a. “Point Estimation for Adaptive Trial Designs i: A Methodological Review.” Statistics in Medicine 42 (2): 122–45. https://doi.org/10.1002/sim.9605.

Robertson, David S., Babak Choodari‐Oskooei, Munya Dimairo, Laura Flight, Philip Pallmann, and Thomas Jaki. 2023b. “Point Estimation for Adaptive Trial Designs II: Practical Considerations and Guidance.” Statistics in Medicine 42 (14): 2496–520. https://doi.org/10.1002/sim.9734.

Rouder, Jeffrey N. 2014. “Optional Stopping: No Problem for Bayesians.” Psychonomic Bulletin & Review 21 (2): 301–8. https://doi.org/10.3758/s13423-014-0595-4.

Rouder, Jeffrey N., Paul L. Speckman, Dongchu Sun, Richard D. Morey, and Geoffrey Iverson. 2009. “Bayesian t Tests for Accepting and Rejecting the Null Hypothesis.” Psychonomic Bulletin & Review 16 (2): 225–37. https://doi.org/10.3758/pbr.16.2.225.

Rushton, S. 1950. “On a Sequential t-Test.” Biometrika 37 (3/4): 326. https://doi.org/10.2307/2332385.

Ryan, Elizabeth G., Kristian Brock, Simon Gates, and Daniel Slade. 2020. “Do We Need to Adjust for Interim Analyses in a Bayesian Adaptive Trial Design?” BMC Medical Research Methodology 20 (1). https://doi.org/10.1186/s12874-020-01042-7.

Scharfstein, Daniel O., Anastasios A. Tsiatis, and James M. Robins. 1997. “Semiparametric Efficiency and Its Implication on the Design and Analysis of Group-Sequential Studies.” Journal of the American Statistical Association 92 (440): 1342–50. https://doi.org/10.1080/01621459.1997.10473655.

Schnuerch, Martin, and Edgar Erdfelder. 2020. “Controlling Decision Errors with Minimal Costs: The Sequential Probability Ratio t Test.” Psychological Methods 25 (2): 206–26. https://doi.org/10.1037/met0000234.

SCHOENFELD, DAVID. 1981. “The Asymptotic Properties of Nonparametric Tests for Comparing Survival Distributions.” Biometrika 68 (1): 316–19. https://doi.org/10.1093/biomet/68.1.316.

Schoenfeld, David A. 1983. “Sample-Size Formula for the Proportional-Hazards Regression Model.” Biometrics 39 (2): 499. https://doi.org/10.2307/2531021.

Schönbrodt, Felix D., and Eric-Jan Wagenmakers. 2018. “Bayes Factor Design Analysis: Planning for Compelling Evidence.” Psychonomic Bulletin & Review 25 (1): 128–42. https://doi.org/10.3758/s13423-017-1230-y.

Schönbrodt, Felix D., Eric-Jan Wagenmakers, Michael Zehetleitner, and Marco Perugini. 2017. “Sequential Hypothesis Testing with Bayes Factors: Efficiently Testing Mean Differences.” Psychological Methods 22 (2): 322–39. https://doi.org/10.1037/met0000061.

Schulz, Kenneth F, and David A Grimes. 2005. “Multiplicity in Randomised Trials II: Subgroup and Interim Analyses.” The Lancet 365 (9471): 1657–61. https://doi.org/10.1016/s0140-6736(05)66516-6.

Schure, Judith ter, and Peter Grünwald. 2022. “ALL-IN Meta-Analysis: Breathing Life into Living Systematic Reviews.” F1000Research 11 (May): 549. https://doi.org/10.12688/f1000research.74223.1.

Schure, Judith ter, Muriel F. Pérez-Ortiz, Alexander Ly, and Peter D. Grünwald. 2024. “The Anytime-Valid Logrank Test: Error Control Under Continuous Monitoring with Unlimited Horizon.” The New England Journal of Statistics in Data Science, 190–214. https://doi.org/10.51387/24-nejsds65.

Silva, I. R., and M. Kulldorff. 2015. “Continuous Versus Group Sequential Analysis for Post‐market Drug and Vaccine Safety Surveillance.” Biometrics 71 (3): 851–58. https://doi.org/10.1111/biom.12324.

Silva, Ivair R., Martin Kulldorff, and W. Katherine Yih. 2020. “Optimal Alpha Spending for Sequential Analysis with Binomial Data.” Journal of the Royal Statistical Society Series B: Statistical Methodology 82 (4): 1141–64. https://doi.org/10.1111/rssb.12379.

Simmonds, Mark, Georgia Salanti, Joanne McKenzie, et al. 2017. “Living Systematic Reviews: 3. Statistical Methods for Updating Meta-Analyses.” Journal of Clinical Epidemiology 91 (November): 38–46. https://doi.org/10.1016/j.jclinepi.2017.08.008.

Simon, Richard. 1989. “Optimal Two-Stage Designs for Phase II Clinical Trials.” Controlled Clinical Trials 10 (1): 1–10. https://doi.org/10.1016/0197-2456(89)90015-9.

Spiegelhalter, David J., Laurence S. Freedman, and Patrick R. Blackburn. 1986. “Monitoring Clinical Trials: Conditional or Predictive Power?” Controlled Clinical Trials 7 (1): 8–17. https://doi.org/10.1016/0197-2456(86)90003-6.

Spiegelhalter, David J., Laurence S. Freedman, and Mahesh K. B. Parmar. 1994. “Bayesian Approaches to Randomized Trials.” Journal of the Royal Statistical Society. Series A (Statistics in Society) 157 (3): 357. https://doi.org/10.2307/2983527.

Stallard, Nigel, Susan Todd, Elizabeth G. Ryan, and Simon Gates. 2020. “Comparison of Bayesian and Frequentist Group-Sequential Clinical Trial Designs.” BMC Medical Research Methodology 20 (1). https://doi.org/10.1186/s12874-019-0892-8.

Stefan, Angelika M., Felix D. Schönbrodt, Nathan J. Evans, and Eric-Jan Wagenmakers. 2022. “Efficiency in Sequential Testing: Comparing the Sequential Probability Ratio Test and the Sequential Bayes Factor Test.” Behavior Research Methods 54 (6): 3100–3117. https://doi.org/10.3758/s13428-021-01754-8.

Steiner, S. H. 2000. “Monitoring Surgical Performance Using Risk-Adjusted Cumulative Sum Charts.” Biostatistics 1 (4): 441–52. https://doi.org/10.1093/biostatistics/1.4.441.

Steinhilber, Meike, Martin Schnuerch, and Anna-Lena Schubert. 2024. “Sequential Analysis of Variance: Increasing Efficiency of Hypothesis Testing.” Psychological Methods, ahead of print. https://doi.org/10.1037/met0000677.

Thall, Peter F., and Richard Simon. 1994. “Practical Bayesian Guidelines for Phase IIB Clinical Trials.” Biometrics 50 (2): 337. https://doi.org/10.2307/2533377.

Todd, Susan. 2007. “A 25‐year Review of Sequential Methodology in Clinical Studies.” Statistics in Medicine 26 (2): 237–52. https://doi.org/10.1002/sim.2763.

Todd, Susan, Anne Whitehead, Nigel Stallard, and John Whitehead. 2001. “Interim Analyses and Sequential Designs in Phase III Studies.” British Journal of Clinical Pharmacology 51 (5): 394–99. https://doi.org/10.1046/j.1365-2125.2001.01382.x.

Tournoux‐Facon, Caroline, Yann De Rycke, and Pascale Tubert‐Bitter. 2011. “Targeting Population Entering Phase III Trials: A New Stratified Adaptive Phase II Design.” Statistics in Medicine 30 (8): 801–11. https://doi.org/10.1002/sim.4148.

Tsiatis, Anastasios A. 1982. “Repeated Significance Testing for a General Class of Statistics Used in Censored Survival Analysis.” Journal of the American Statistical Association 77 (380): 855–61. https://doi.org/10.1080/01621459.1982.10477898.

Tsiatis, Anastasios A., Gary L. Rosner, and Cyrus R. Mehta. 1984. “Exact Confidence Intervals Following a Group Sequential Test.” Biometrics 40 (3): 797. https://doi.org/10.2307/2530924.

Tymofyeyev, Yevgen. 2014. “A Review of Available Software and Capabilities for Adaptive Designs.” In Practical Considerations for Adaptive Trial Design and Implementation. Springer New York. https://doi.org/10.1007/978-1-4939-1100-4_8.

U.S. Food and Drug Administration. 2019. Adaptive Designs for Clinical Trials of Drugs and Biologics: Guidance for Industry.

Vovk, Vladimir, and Ruodu Wang. 2021. “E-Values: Calibration, Combination and Applications.” The Annals of Statistics 49 (3). https://doi.org/10.1214/20-aos2020.

Wald, A. 1945. “Sequential Tests of Statistical Hypotheses.” The Annals of Mathematical Statistics 16 (2): 117–86. https://doi.org/10.1214/aoms/1177731118.

Wald, Abraham. 1947. Sequential Analysis. Wiley.

Wang, Samuel K., and Anastasios A. Tsiatis. 1987. “Approximately Optimal One-Parameter Boundaries for Group Sequential Trials.” Biometrics 43 (1): 193. https://doi.org/10.2307/2531959.

Wassmer, Gernot, and Werner Brannath. 2016. Group Sequential and Confirmatory Adaptive Designs in Clinical Trials. In Springer Series in Pharmaceutical Statistics. Springer International Publishing. https://doi.org/10.1007/978-3-319-32562-0.

Wassmer, Gernot, and Marc Vandemeulebroecke. 2006. “A Brief Review on Software Developments for Group Sequential and Adaptive Designs.” Biometrical Journal 48 (4): 732–37. https://doi.org/10.1002/bimj.200510233.

Waudby-Smith, Ian, David Arbour, Ritwik Sinha, Edward H. Kennedy, and Aaditya Ramdas. 2024. “Time-Uniform Central Limit Theory and Asymptotic Confidence Sequences.” The Annals of Statistics 52 (6). https://doi.org/10.1214/24-aos2408.

Wetterslev, Jørn, Janus Christian Jakobsen, and Christian Gluud. 2017. “Trial Sequential Analysis in Systematic Reviews with Meta-Analysis.” BMC Medical Research Methodology 17 (1). https://doi.org/10.1186/s12874-017-0315-7.

Wetterslev, Jørn, Kristian Thorlund, Jesper Brok, and Christian Gluud. 2008. “Trial Sequential Analysis May Establish When Firm Evidence Is Reached in Cumulative Meta-Analysis.” Journal of Clinical Epidemiology 61 (1): 64–75. https://doi.org/10.1016/j.jclinepi.2007.03.013.

Whitehead, John. 1997. The Design and Analysis of Sequential Clinical Trials. 2nd revised. Wiley.

Whitehead, John. 1999. “A Unified Theory for Sequential Clinical Trials.” Statistics in Medicine 18 (17-18): 2271–86. https://doi.org/10.1002/(sici)1097-0258(19990915/30)18:17/18<2271::aid-sim254>3.0.co;2-z.

Whitehead, John. 2004. “Stopping Clinical Trials by Design.” Nature Reviews Drug Discovery 3 (11): 973–77. https://doi.org/10.1038/nrd1553.

Whitehead, John, and David Jones. 1979. “The Analysis of Sequential Clinical Trials.” Biometrika 66 (3): 443–52. https://doi.org/10.1093/biomet/66.3.443.

Whitehead, John, and Irene Stratton. 1983. “Group Sequential Clinical Trials with Triangular Continuation Regions.” Biometrics 39 (1): 227. https://doi.org/10.2307/2530822.

Woodall, William H. 2006. “The Use of Control Charts in Health-Care and Public-Health Surveillance.” Journal of Quality Technology 38 (2): 89–104. https://doi.org/10.1080/00224065.2006.11918593.

Yanagida, Takuya. 2017. “Seqtest: An r Package for Sequential Triangular Tests.” Journal of Statistical Theory and Practice 11 (3): 402–6. https://doi.org/10.1080/15598608.2016.1268549.

Yih, W. Katherine, Martin Kulldorff, Bruce H. Fireman, et al. 2011. “Active Surveillance for Adverse Events: The Experience of the Vaccine Safety Datalink Project.” Pediatrics 127 (Supplement_1): S54–64. https://doi.org/10.1542/peds.2010-1722i.

Zang, Yong, and Ying Yuan. 2016. “Optimal Sequential Enrichment Designs for Phase II Clinical Trials.” Statistics in Medicine 36 (1): 54–66. https://doi.org/10.1002/sim.7128.

Zhou, Heng, J. Jack Lee, and Ying Yuan. 2017. “BOP2: Bayesian Optimal Design for Phase II Clinical Trials with Simple and Complex Endpoints.” Statistics in Medicine 36 (21): 3302–14. https://doi.org/10.1002/sim.7338.

Zhu, Li, Liyun Ni, and Bin Yao. 2011. “Group Sequential Methods and Software Applications.” The American Statistician 65 (2): 127–35. https://doi.org/10.1198/tast.2011.10213.