Enhancing randomized clinical trials with digital twins

  • Determinants of health. https://www.who.int/news-room/questions-and-answers/item/determinants-of-health#:~:text=The%20determinants%20of%20health%20include,person’s%20individual%20characteristics%20and%20behaviours (2024).

  • Wakefield, M. K., Williams, D. R., Le Menestrel, S. & Lalitha, J. The Future of Nursing 2020–2030: Charting a Path to Achieve Health Equity (National Academies Press, 2021).

  • Mendelsohn, A. B. et al. Characterization of missing data in clinical registry studies. Ther. Innov. Regul. Sci. 49, 146–154 (2015).

    Article 
    PubMed 

    Google Scholar 

  • Gliklich, R. E., Leavy, M. B. & Dreyer, N. A. Tools and technologies for registry interoperability, registries for evaluating patient outcomes: a user’s guide, addendum 2. Agency for Healthcare Research and Quality (2019).

  • Fernainy, P. et al. BMC Proceedings (Springer).

  • Kandi, V. & Vadakedath, S. Clinical trials and clinical research: a comprehensive review. Cureus 15, e35077 (2023).

  • Averitt, A. J., Ryan, P. B., Weng, C. & Perotte, A. A conceptual framework for external validity. J. Biomed. Inform. 121, 103870 (2021).

    Article 
    PubMed 

    Google Scholar 

  • Ytterberg, S. R. et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N. Engl. J. Med. 386, 316–326 (2022).

    Article 
    CAS 
    PubMed 

    Google Scholar 

  • Lee, D. et al. genrct: a statistical analysis framework for generalizing RCT findings to real-world population. J. Biopharm. Stat. 34, 873–892 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Hernandez, I., Baik, S. H., Piñera, A. & Zhang, Y. Risk of bleeding with dabigatran in atrial fibrillation. JAMA Intern. Med. 175, 18–24 (2015).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Alarcón Garavito, G. A. et al. Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review. Trials 26, 65 (2025).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Getz, K. How much does a day of delay in a clinical trial really cost? Appl. Clin. Trials 33 (2024).

  • Chandra, S., Prakash, P., Samanta, S. & Chilukuri, S. ClinicalGAN: powering patient monitoring in clinical trials with patient digital twins. Sci. Rep. 14, 12236 (2024).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Lamberti, J. inHEART initiates randomized controlled trial for its AI-enabled digital twin of the heart. https://www.inheartmedical.com/news/inheart-initiates-randomized-controlled-trial-for-its-ai-enabled-digital-twin-of-the-heart (2025).

  • Matzenbacher, L. S. et al. Interactive virtual assistant for health promotion and diabetes care in older adults with diabetes—a randomized controlled trial. Diabetes 74, 297-OR (2025).

    Article 

    Google Scholar 

  • Lam, T. Y. et al. Randomized controlled trials of artificial intelligence in clinical practice: systematic review. J. Med. Internet Res. 24, e37188 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Akbarialiabad, H. et al. Bridging silicon and carbon worlds with digital twins and on-chip systems in drug discovery. npj Syst. Biol. Appl. 10, 150 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Tao, F. & Qi, Q. Make more digital twins. Nature 573, 490–491 (2019).

    Article 
    CAS 
    PubMed 

    Google Scholar 

  • Wang, G. et al. Development of metaverse for intelligent healthcare. Nat. Mach. Intell. 4, 922–929 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Voigt, I. et al. Digital twins for multiple sclerosis. Front. Immunol. 12, 669811 (2021).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Wu, C. et al. Integrating mechanism-based modeling with biomedical imaging to build practical digital twins for clinical oncology. Biophys. Rev. 3, 021304 (2022).

  • Grieb, N. et al. A digital twin model for evidence-based clinical decision support in multiple myeloma treatment. Front. Digit. Health 5, 1324453 (2023).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Vidovszky, A. A. et al. Increasing acceptance of AI-generated digital twins through clinical trial applications. Clin. Transl. Sci. 17, e13897 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Ghaffar Nia, N., Kaplanoglu, E. & Nasab, A. Evaluation of artificial intelligence techniques in disease diagnosis and prediction. Discov. Artif. Intell. 3, 5 (2023).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Croatti, A., Gabellini, M., Montagna, S. & Ricci, A. On the integration of agents and digital twins in healthcare. J. Med. Syst. 44, 161 (2020).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Ross, J. L., Sabbaghi, A., Zhuang, R., Bertolini, D. & Initiative, A. s. D. N. Enhancing longitudinal clinical trial efficiency with digital twins and prognostic covariate-adjusted mixed models for repeated measures (PROCOVA-MMRM). Preprint at arXiv:2404.17576 (2024).

  • Schwartz, S. M., Wildenhaus, K., Bucher, A. & Byrd, B. Digital twins and the emerging science of self: implications for digital health experience design and “small” data. Front. Comput. Sci. 2, 31 (2020).

    Article 

    Google Scholar 

  • Jung, A., Gsell, M. A., Augustin, C. M. & Plank, G. An integrated workflow for building digital twins of cardiac electromechanics—a multi-fidelity approach for personalising active mechanics. Mathematics 10, 823 (2022).

    Article 
    PubMed 

    Google Scholar 

  • Barat, S. et al. An agent-based digital twin for exploring localized non-pharmaceutical interventions to control covid-19 pandemic. Trans. Indian Natl Acad. Eng. 6, 323–353 (2021).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Martinez-Velazquez, R., Gamez, R. & El Saddik, A. In 2019 IEEE International Symposium on Medical Measurements and Applications (MeMeA) 1–6 (IEEE, 2019).

  • Joslyn, L. R., Huang, W., Miles, D., Hosseini, I. & Ramanujan, S. Digital twins elucidate critical role of Tscm in clinical persistence of TCR-engineered cell therapy. NPJ Syst. Biol. Appl. 10, 11 (2024).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Sinisi, S. et al. Optimal personalised treatment computation through in silico clinical trials on patient digital twins. Fundam. Inform. 174, 283–310 (2020).

    Article 

    Google Scholar 

  • Inan, O. T. et al. Digitizing clinical trials. NPJ Digit. Med. 3, 1–7 (2020).

    Article 

    Google Scholar 

  • Rodriguez-Chavez, I. R. & Licholai, G. in Digital Therapeutics (Chapman and Hall/CRC, 2022).

  • Stahlberg, E. et al. Exploring approaches for predictive cancer patient digital twins: opportunities for collaboration and innovation. Front. Digit. Health https://doi.org/10.3389/fdgth.2022.1007784 (2022).

  • Benson, M. Digital twins for predictive, preventive personalized, and participatory treatment of immune-mediated diseases. Arterioscler. Thromb. Vasc. Biol. 43, 410–416 (2023).

    Article 
    CAS 
    PubMed 

    Google Scholar 

  • Karakra, A. HospiT’Win: designing a discrete event simulation-based digital twin for real-time monitoring and near-future prediction of patient pathways in the hospital, Ecole des Mines d’Albi-Carmaux, (2021).

  • Bordukova, M., Makarov, N., Rodriguez-Esteban, R., Schmich, F. & Menden, M. P. Generative artificial intelligence empowers digital twins in drug discovery and clinical trials. Expert Opin. Drug Discov. 19, 33–42 (2024).

    Article 
    CAS 
    PubMed 

    Google Scholar 

  • Lapid, M., Clarke, B. & Wright, S. Institutional review boards: what clinician researchers need to know. Mayo Clin. Proc. 94, 515 (2019).

    Article 
    PubMed 

    Google Scholar 

  • Weijer, C. The ethical analysis of risk. J. Law Med. Ethics 28, 344–361 (2000).

    Article 
    CAS 
    PubMed 

    Google Scholar 

  • Bruynseels, K., Santoni de Sio, F. & van den Hoven, J. Digital twins in health care: ethical implications of an emerging Engineering paradigm. Front. Genet. 9, 31 (2018).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Wang, Y. et al. TWIN-GPT: digital twins for clinical trials via large language model. In ACM Transactions on Multimedia Computing, Communications and Applications (ACM, 2024).

  • Rahmim, A. et al. Theranostic digital twins for personalized radiopharmaceutical therapies: reimagining theranostics via computational nuclear oncology. Front. Oncol. 12, 1062592 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Cellina, M. et al. Digital twins: the new frontier for personalized medicine?. Appl. Sci. 13, 7940 (2023).

    Article 
    CAS 

    Google Scholar 

  • Mulder, S. T. et al. Dynamic digital twin: diagnosis, treatment, prediction, and prevention of disease during the life course. J. Med. Internet Res. 24, e35675 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Akbarialiabad, H., Pasdar, A. & Murrell, D. F. Digital twins in dermatology, current status, and the road ahead. NPJ Digit. Med. 7, 228 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • An, G. & Cockrell, C. Drug development digital twins for drug discovery, testing and repurposing: a schema for requirements and development. Front. Syst. Biol. 2, 928387 (2022).

    Article 
    PubMed 

    Google Scholar 

  • Waight, M. C. et al. Personalized heart digital twins detect substrate abnormalities in scar-dependent ventricular tachycardia. Circulation 151, 521–533 (2025).

    Article 
    PubMed 

    Google Scholar 

  • Allen, A. et al. A digital twins machine learning model for forecasting disease progression in stroke patients. Appl. Sci. 11, 5576 (2021).

    Article 
    CAS 

    Google Scholar 

  • Wong, C. H., Siah, K. W. & Lo, A. W. Estimation of clinical trial success rates and related parameters. Biostatistics 20, 273–286 (2019).

    Article 
    PubMed 

    Google Scholar 

  • Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M. & Granger, C. B. Fundamentals of Clinical Trials (Springer, 2015).

  • Brøgger-Mikkelsen, M., Ali, Z., Zibert, J. R., Andersen, A. D. & Thomsen, S. F. Online patient recruitment in clinical trials: systematic review and meta-analysis. J. Med. Internet Res. 22, e22179 (2020).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Huang, P. -h, Kim, K. -h & Schermer, M. Ethical issues of digital twins for personalized health care service: preliminary mapping study. J. Med. Internet Res. 24, e33081 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Thangaraj, P. M. et al. A novel digital twin strategy to examine the implications of randomized clinical trials for real-world populations. Preprint at medRxiv (2024).

  • Popa, E. O., van Hilten, M., Oosterkamp, E. & Bogaardt, M.-J. The use of digital twins in healthcare: socio-ethical benefits and socio-ethical risks. Life Sci. Soc. Policy 17, 1–25 (2021).

    Article 

    Google Scholar 

  • Greenbaum, D. in Biocomputing 2021: Proceedings of the Pacific Symposium 38–49 (World Scientific, 2021).

  • Shapiro, M. A digital twin for individualized cardiology. HopkinsMedicine.org. https://www.hopkinsmedicine.org/news/articles/2025/05/a-digital-twin-for-individualized-cardiology (2025).

  • Abujarad, F. et al. Comparing a multimedia digital informed consent tool with traditional paper-based methods: randomized controlled trial. JMIR Form. Res. 5, e20458 (2021).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Inan, O. T. et al. Digitizing clinical trials. NPJ Digit. Med. 3, 101 (2020).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Jørgensen, C. S., Shukla, A. & Katt, B. in European Symposium on Research in Computer Security 140–153 (Springer).

  • Twin Health. Twin Health’s security overview. Twin Health security and compliance. https://usa.twinhealth.com/legal/security-and-compliance (2025).

  • Jameil, A. K. & Al-Raweshidy, H. A digital twin framework for real-time healthcare monitoring: leveraging AI and secure systems for enhanced patient outcomes. Discov. Internet Things 5, 37 (2025).

    Article 

    Google Scholar 

  • Zhang, J. et al. Cyber resilience in healthcare digital twin on lung cancer. IEEE Access 8, 201900–201913 (2020).

    Article 

    Google Scholar 

  • Rahman, H. U. et al. To explore the pharmacological mechanism of action using digital twin. Int. J. Adv. Appl. Sci. 9, 55–62 (2022).

    Article 

    Google Scholar 

  • Subramanian, K. Digital twin for drug discovery and development—the virtual liver. J. Indian Inst. Sci. 100, 653–662 (2020).

    Article 

    Google Scholar 

  • Faruqui, S. H. A. et al. Nurse-in-the-loop artificial intelligence for precision management of type 2 diabetes in a clinical trial utilizing transfer-learned predictive digital twin. preprint at arXiv:2401.02661 (2024).

  • Thorlund, K., Dron, L., Park, J. J. H. & Mills, E. J. Synthetic and external controls in clinical trials – a primer for researchers. Clin. Epidemiol. 12, 457–467 (2020).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Wang, Z., Butner, J. D., Kerketta, R., Cristini, V. & Deisboeck, T. S. Simulating cancer growth with multiscale agent-based modeling. Semin. Cancer Biol. 30, 70–78 (2015).

  • Højbjerre-Frandsen, E., Jeppesen, M. L. & Jensen, R. K. Increasing the Power in Randomised Clinical Trials Using Digital Twins. Master’s thesis, Aalborg Univ. (2022).

  • Attaran, M., Attaran, S. & Celik, B. G. Revolutionizing agriculture through digital twins. Encyclopedia of Information Science and Technology, Sixth Edition. 1–14 (2025).

  • Lal, A., Dang, J., Nabzdyk, C., Gajic, O. & Herasevich, V. Regulatory oversight and ethical concerns surrounding software as medical device (SaMD) and digital twin technology in healthcare. Ann. Transl. Med. https://doi.org/10.21037/atm-22-4203 (2022).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Zoltick, M. M. & Maisel, J. B. The Digital Twin (Springer, 2023).

  • Currie, G. M., Hawk, K. E. & Rohren, E. M. The potential role of artificial intelligence in sustainability of nuclear medicine.Radiography (Lond.) 30 (Suppl. 1), 119–124 https://doi.org/10.1016/j.radi.2024.03.005 (2024).

  • Mehrabi, N., Morstatter, F., Saxena, N., Lerman, K. & Galstyan, A. A survey on bias and fairness in machine learning. ACM Comput. Surv. (CSUR) 54, 1–35 (2021).

    Article 

    Google Scholar 

  • Mariam, Z., Niazi, S. K. & Magoola, M. Unlocking the future of drug development: generative AI, digital twins, and beyond. BioMedInformatics 4, 1441–1456 (2024).

    Article 

    Google Scholar 

  • MacDonald, J. et al. Health technology for all: an equity-based paradigm shift opportunity. NAM Perspect. https://doi.org/10.31478/202212a (2022).

  • Ferlito, B., De Proost, M. & Segers, S. Navigating the landscape of digital twins in medicine: a relational bioethical inquiry. Asian Bioeth. Rev. 16, 471–481 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Willison, R., Lowry, P. B. & Paternoster, R. A tale of two deterrents: considering the role of absolute and restrictive deterrence to inspire new directions in behavioral and organizational security research. J. Assoc. Inf. Syst. 19, 3 (2018).

    Google Scholar 

  • Suhail, S., Jurdak, R. & Hussain, R. Security attacks and solutions for digital twins. Preprint at arXiv:2202.12501 (2022).

  • XM Cyber. How digital twins are revolutionizing threat management. https://xmcyber.com/blog/how-digital-twins-are-revolutionizing-threat-management/ (2025).

  • Nugent, T., Upton, D. & Cimpoesu, M. Improving data transparency in clinical trials using blockchain smart contracts. F1000Res 5, 2541 (2016).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Amofa, S. et al. Blockchain-secure patient digital twin in healthcare using smart contracts. PLoS ONE 19, e0286120 (2024).

    Article 
    CAS 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Kasyapa, M. S. B. & Vanmathi, C. Blockchain integration in healthcare: a comprehensive investigation of use cases, performance issues, and mitigation strategies. Front. Digit. Health 6, 1359858 (2024).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Hirano, T. et al. Data validation and verification using blockchain in a clinical trial for breast cancer: regulatory sandbox. J. Med. Internet Res. 22, e18938 (2020).

    Article 
    PubMed 
    PubMed Central 

    Google Scholar 

  • Continue Reading