References

Angrist, Joshua D., and Jorn-Steffen Pischke. 2009. Mostly Harmless Econometrics: An Empiricist’s Companion. Princeton University Press. https://doi.org/10.2307/j.ctvcm4j72.
Angrist, Joshua D., and Jörn-Steffen Pischke. 2015. “Mastering ’Metrics: The Path from Cause to Effect.” 2015. https://press.princeton.edu/books/paperback/9780691152844/mastering-metrics.
Ankan, Ankur, Inge M. N. Wortel, and Johannes Textor. 2021. “Testing Graphical Causal Models Using the R Package ‘Dagitty’.” Current Protocols 1 (2): e45. https://doi.org/10.1002/cpz1.45.
Begg, Colin, Mildred Cho, Susan Eastwood, Richard Horton, David Moher, Ingram Olkin, Roy Pitkin, et al. 1996. “Improving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement.” JAMA 276 (8): 637–39. https://doi.org/10.1001/jama.1996.03540080059030.
Bothwell, Laura E., Jerry Avorn, Nazleen F. Khan, and Aaron S. Kesselheim. 2018. “Adaptive Design Clinical Trials: A Review of the Literature and ClinicalTrials.gov.” BMJ Open 8 (2): e018320. https://doi.org/10.1136/bmjopen-2017-018320.
Chan, An-Wen, Jennifer M. Tetzlaff, Douglas G. Altman, Andreas Laupacis, Peter C. Gøtzsche, Karmela Krleža-Jerić, Asbjørn Hróbjartsson, et al. 2013. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.” Annals of Internal Medicine 158 (3): 200–207. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.
Chan, An-Wen, Jennifer M. Tetzlaff, Peter C. Gøtzsche, Douglas G. Altman, Howard Mann, Jesse A. Berlin, Kay Dickersin, et al. 2013. SPIRIT 2013 Explanation and Elaboration: Guidance for Protocols of Clinical Trials.” BMJ 346 (January): e7586. https://doi.org/10.1136/bmj.e7586.
Cunningham, Scott. 2021. Causal Inference: The Mixtape. Yale University Press. https://doi.org/10.2307/j.ctv1c29t27.
———. 2025. “Mixtape Sessions (Github).” 2025. https://github.com/Mixtape-Sessions.
Digitale, Jean C., Jeffrey N. Martin, and Medellena Maria Glymour. 2022. “Tutorial on Directed Acyclic Graphs.” Journal of Clinical Epidemiology 142 (February): 264–67. https://doi.org/10.1016/j.jclinepi.2021.08.001.
Fisher, R A, and F Yates. 1990. Statistical Methods, Experimental Design, and Scientific Inference: A Re-issue of Statistical Methods for Research Workers, the Design of Experiments and Statistical Methods and Scientific Inference. Edited by J H Bennett. Oxford University Press. https://doi.org/10.1093/oso/9780198522294.001.0001.
Fisher, Ronald A. 1925. “Statistical Methods for Research Workers (Scan of 1st Edition).” Classics in the History of Psychology. 1925. https://psychclassics.yorku.ca/Fisher/Methods/.
Greenland, Sander, Judea Pearl, and James M. Robins. 1999. “Causal Diagrams for Epidemiologic Research.” Epidemiology 10 (1): 37. https://journals.lww.com/epidem/abstract/1999/01000/causal_diagrams_for_epidemiologic_research.8.aspx?casa_token=t1bYrLdrL5EAAAAA:jek7bcCsZNWdAWZSBuH4WUKpadC7BXnvKae9-OTeDK57f6KworoLmwgGS6PNX3AQRq8JEB4WL12pwWt-l9cMm5g_JwByHr78.
Hemming, K., T. P. Haines, P. J. Chilton, A. J. Girling, and R. J. Lilford. 2015. “The Stepped Wedge Cluster Randomised Trial: Rationale, Design, Analysis, and Reporting.” BMJ 350 (February): h391. https://doi.org/10.1136/bmj.h391.
Hernán, Miguel. 2017. “Causal Diagrams: Draw Your Assumptions Before Your Conclusions (Online Course).” Harvard University. August 16, 2017. https://pll.harvard.edu/course/causal-diagrams-draw-your-assumptions-your-conclusions.
Hernán, Miguel A., and James M. Robins. 2016. “Using Big Data to Emulate a Target Trial When a Randomized Trial Is Not Available.” American Journal of Epidemiology 183 (8): 758–64. https://doi.org/10.1093/aje/kwv254.
———. 2025. Causal Inference: What If. Boca Raton: Chapman & Hall/CRC. https://miguelhernan.org/whatifbook.
Hill, Austin Bradford. 1965. “The Environment and Disease: Association or Causation?” Proceedings of the Royal Society of Medicine 58 (5): 295–300. https://doi.org/10.1177/003591576505800503.
HM Treasury. 2020. Magenta Book: Central Government Guidance on Evaluation. United Kingdom: HM Treasury. https://assets.publishing.service.gov.uk/media/5e96cab9d3bf7f412b2264b1/HMT_Magenta_Book.pdf.
Holland, Paul W., Clark Glymour, and Clive Granger. 1985. “Statistics and Causal Inference.” ETS Research Report Series 1985 (2): i–72. https://doi.org/10.1002/j.2330-8516.1985.tb00125.x.
Hussey, Michael A., and James P. Hughes. 2007. “Design and Analysis of Stepped Wedge Cluster Randomized Trials.” Contemporary Clinical Trials 28 (2): 182–91. https://doi.org/10.1016/j.cct.2006.05.007.
Igelström, Erik, Peter Craig, Jim Lewsey, John Lynch, Anna Pearce, and Srinivasa Vittal Katikireddi. 2022. “Causal Inference and Effect Estimation Using Observational Data.” J Epidemiol Community Health 76 (11): 960–66. https://doi.org/10.1136/jech-2022-219267.
Imbens, Guido W. 2020. “Potential Outcome and Directed Acyclic Graph Approaches to Causality: Relevance for Empirical Practice in Economics.” Journal of Economic Literature 58 (4): 1129–79. https://doi.org/10.1257/jel.20191597.
Imbens, Guido W., and Donald B. Rubin. 2015. Causal Inference for Statistics, Social, and Biomedical Sciences: An Introduction. Cambridge: Cambridge University Press. https://doi.org/10.1017/CBO9781139025751.
Jennison, Christopher, and Bruce W. Turnbull. 1999. Group Sequential Methods with Applications to Clinical Trials. New York: Chapman and Hall/CRC. https://doi.org/10.1201/9780367805326.
Kidwell, Kelley M., and Daniel Almirall. 2023. “Sequential, Multiple Assignment, Randomized Trial Designs.” JAMA 329 (4): 336–37. https://doi.org/10.1001/jama.2022.24324.
Lau, Wallis C. Y., Carmen Olga Torre, Kenneth K. C. Man, Henry Morgan Stewart, Sarah Seager, Mui Van Zandt, Christian Reich, et al. 2022. “Comparative Effectiveness and Safety Between Apixaban, Dabigatran, Edoxaban, and Rivaroxaban Among Patients With Atrial Fibrillation.” Annals of Internal Medicine 175 (11): 1515–24. https://doi.org/10.7326/M22-0511.
Markozannes, Georgios, Georgia Vourli, and Evangelia Ntzani. 2021. “A Survey of Methodologies on Causal Inference Methods in Meta-Analyses of Randomized Controlled Trials.” Systematic Reviews 10 (1): 170. https://doi.org/10.1186/s13643-021-01726-1.
Mill, John Stuart. 1843. A System of Logic, Ratiocinative and Inductive: Being a Connected View of the Principles of Evidence, and the Methods of Scientific Investigation. Vol. 1. Cambridge Library Collection - Philosophy. Cambridge: Cambridge University Press. https://doi.org/10.1017/CBO9781139149839.
Morgan, Stephen L., and Christopher Winship. 2014. Counterfactuals and Causal Inference: Methods and Principles for Social Research. 2nd ed. Analytical Methods for Social Research. Cambridge: Cambridge University Press. https://doi.org/10.1017/CBO9781107587991.
Neal, Brady. 2019. “Which Causal Inference Book You Should Read.” November 23, 2019. https://www.bradyneal.com/which-causal-inference-book.
NICE. 2012. “Appendix E Algorithm for Classifying Quantitative (Experimental and Observational) Study Designs | Methods for the Development of NICE Public Health Guidance (Third Edition).” NICE. September 26, 2012. https://www.nice.org.uk/process/pmg4/chapter/appendix-e-algorithm-for-classifying-quantitative-experimental-and-observational-study-designs.
OHID. 2021a. “Guidance: Choose Evaluation Methods: Evaluating Digital Health Products.” GOV.UK. May 19, 2021. https://www.gov.uk/guidance/choose-evaluation-methods-evaluating-digital-health-products.
———. 2021b. “Guidance: Quasi-experimental Study: Comparative Studies.” GOV.UK. September 8, 2021. https://www.gov.uk/guidance/quasi-experimental-study-comparative-studies.
Park, Jay J. H., Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund, and Edward J. Mills. 2019. “Systematic Review of Basket Trials, Umbrella Trials, and Platform Trials: A Landscape Analysis of Master Protocols.” Trials 20 (1): 572. https://doi.org/10.1186/s13063-019-3664-1.
Pearl, Judea. 1995. “Causal Diagrams for Empirical Research.” Biometrika 82 (4): 669–88. https://doi.org/10.1093/biomet/82.4.669.
———. 2009. Causality: Models, Reasoning, and Inference. 2nd ed. Cambridge: Cambridge University Press. https://doi.org/10.1017/CBO9780511803161.
Pearl, Judea, Madelyn Glymour, and Nicholas P. Jewell. 2016. Causal Inference in Statistics: A Primer. Wiley. https://www.wiley.com/en-us/Causal+Inference+in+Statistics%3A+A+Primer-p-9781119186861.
Pearl, Judea, and Dana Mackenzie. 2018. “The Book of Why: The New Science of Cause and Effect.” Guide books. 2018. https://dl.acm.org/doi/book/10.5555/3238230.
Piantadosi, Steven, and Curtis L. Meinert, eds. 2022. Principles and Practice of Clinical Trials. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-52636-2_196.
Pocock, Stuart J. 2013. Clinical Trials: A Practical Approach. John Wiley & Sons, Ltd. https://doi.org/10.1002/9781118793916.fmatter.
Rosenbaum, Paul R. 2017. Observation and Experiment: An Introduction to Causal Inference. Harvard University Press. https://www.jstor.org/stable/j.ctv253f7k2.
———. 2020. Design of Observational Studies. Springer Series in Statistics. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-030-46405-9.
———. 2023. Causal Inference. The MIT Press. https://doi.org/10.7551/mitpress/14244.001.0001.
Royston, Patrick, Friederike M-S Barthel, Mahesh KB Parmar, Babak Choodari-Oskooei, and Valerie Isham. 2011. “Designs for Clinical Trials with Time-to-Event Outcomes Based on Stopping Guidelines for Lack of Benefit.” Trials 12 (1): 81. https://doi.org/10.1186/1745-6215-12-81.
Rubin, Donald B. 1974. “Estimating Causal Effects of Treatments in Randomized and Nonrandomized Studies.” Journal of Educational Psychology 66 (5): 688–701. https://doi.org/10.1037/h0037350.
———. 1986. “Statistics and Causal Inference: Comment: Which Ifs Have Causal Answers.” Journal of the American Statistical Association 81 (396): 961–62. https://doi.org/10.2307/2289065.
Schiff, A, L Wright, and T Denne. 2017. “Ex-Post Evaluation of Transport Interventions Using Causal Inference Methods.” NZ Transport Agency Waka Kotahi. https://nzta.govt.nz/resources/research/reports/630/.
Shadish, William R., Thomas D. Cook, and Donald T. Campbell. 2002. Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Experimental and Quasi-Experimental Designs for Generalized Causal Inference. Boston, MA, US: Houghton, Mifflin and Company.
Splawa-Neyman, Jerzy, D. M. Dabrowska, and T. P. Speed. 1990. “On the Application of Probability Theory to Agricultural Experiments. Essay on Principles. Section 9.” Statistical Science 5 (4): 465–72. https://doi.org/10.1214/ss/1177012031.
Van Der Laan, Mark J., and Sherri Rose. 2011. Targeted Learning: Causal Inference for Observational and Experimental Data. Springer Series in Statistics. New York, NY: Springer. https://doi.org/10.1007/978-1-4419-9782-1.
———. 2018. Targeted Learning in Data Science: Causal Inference for Complex Longitudinal Studies. Springer Series in Statistics. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-65304-4.
Vanderweele, Tyler J. 2015. Explanation in Causal Inference: Methods for Mediation and Interaction. Explanation in Causal Inference: Methods for Mediation and Interaction. New York, NY, US: Oxford University Press.
Vigen, Tyler. 2024. “Tyler Vigen Spurious Correlation #1,172: Butter Consumption Correlates with Economic Output of Washington Metro Area.” TylerVigen.com. January 2024. https://tylervigen.com/spurious/correlation/1172_butter-consumption_correlates-with_economic-output-of-washington-metro-area.
Wang, Duolao, and Ameet Bakhai. 2006. Clinical Trials: A Practical Guide to Design, Analysis, and Reporting. Remedica.
Wason, James M. S., and Thomas Jaki. 2012. “Optimal Design of Multi-Arm Multi-Stage Trials.” Statistics in Medicine 31 (30): 4269–79. https://doi.org/10.1002/sim.5513.
Wason, James, Dominic Magirr, Martin Law, and Thomas Jaki. 2012. “Some Recommendations for Multi-Arm Multi-Stage Trials.” Statistical Methods in Medical Research, December. https://doi.org/10.1177/0962280212465498.