ВИКОРИСТАННЯ ЦИФРОВИХ ТЕХНОЛОГІЙ У ЗАБЕЗПЕЧЕННІ ЯКОСТІ РЕАЛІЗАЦІЇ ПРОЕКТІВ КЛІНІЧНИХ ВИПРОБУВАНЬ: КОМПЛЕКСНИЙ ОГЛЯД
Анотація
У статті розглядаються особливості цифрової трансформації клінічних випробувань та застосування окремих цифрових технологій, що суттєво змінюють підходи до забезпечення якості клінічних досліджень, пропонуючи інструменти для підвищення точності й достовірності отриманих даних, гарантування безпеки учасників дослідження, підвищення ефективності моніторингу та забезпечення відповідності регуляторним нормам. Авторами виконано комплексний аналіз сучасного стану використання цифрових технологій у сфері забезпечення якості проведення клінічних випробувань на основі системного огляду наукових публікацій здебільшого закордонних дослідників за період з 2004 по 2026 роки. У статті виконано аналіз категорій цифрових інструментів, що охоплюють системи електронного збору даних та електронні первинні дані, моніторинг на основі ризиків із централізованою аналітикою, застосування штучного інтелекту та машинного навчання, цифрові медичні технології та носимі пристрої, а також новітні перспективні рішення на основі блокчейну.
Посилання
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Stafford P.B., Garrett A. Using real-time data to drive better decisions, faster. Therapeutic Innovation and Regulatory Science. 2011. Vol. 45. № 4. Pp. 495-502. DOI: https://doi.org/10.1177/009286151104500410.
Zhang J., Sun L., Liu Y., Wang H., Sun N., Zhang P. Mobile device-based electronic data capture system used in a clinical randomized controlled trial: advantages and challenges. Journal of Medical Internet Research. 2017. Vol. 19. № 3, Article e66. DOI: https://doi.org/10.2196/jmir.6978.
Daher A. et al. A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data. PLOS ONE. 2023. Vol. 18. № 11. DOI: https://doi.org/10.1371/journal.pone.0294412.
Barnes S., Katta N., Sanford N. et al. Technology considerations to enable the risk-based monitoring methodology. Therapeutic Innovations & Regulatory Science. 2014. Vol. 48. № 5. Pp. 536-545. DOI: https://doi.org/10.1177/2168479014546336.
Kommaraju R.J. Optimizing data quality and compliance through integrated validation strategies for clinical systems. The American Journal of Engineering and Technology. 2025. Vol. 7. № 8. Pp. 299-306. DOI: https://doi.org/10.37547/tajet/Volume07Issue08-26.
Sahoo U., Bhatt A. Electronic data capture (EDC) – A new mantra for clinical trials. Quality Assurance. 2004. Vol. 10. № 3-4. Pp. 117-121. DOI: https://doi.org/10.1080/10529410390892052.
Paul S. Data integrity and quality in clinical trials. Revista de Inteligencia Artificial en Medicina. 2024. Vol. 15. № 1. URL: https://redcrevistas.com/index.php/Revista/article/view/266 (дата звернення: 06.04.2026).
Yamada, O., Chiu, S. W., Nakazawa, T. et al. (2024). Effectiveness of remote risk-based monitoring and potential benefits for combination with direct data capture. Trials, 25, 384. https://doi.org/10.1186/s13063-024-08242-2.
Mitchel, J. T., Schloss Markowitz, J. M., Yin, H. et al. (2012). Lessons learned from a direct data entry phase 2 clinical trial under a US investigational new drug application. Therapeutic Innovation and Regulatory Science, 46(4), 464-471. https://doi.org/10.1177/0092861512449530.
Jiang, M., Zhao, S., Mei, Y., Fu, Z., Yuan, Y., Ai, J., Sheng, Y., Gong, Y. & Chen, J. (2025). Real-time, risk-based clinical trial quality management in China: development of a digital monitoring platform. Journal of Medical Internet Research – Medical Informatics, 13, e64114. https://doi.org/10.2196/64114.
Yamada, O., Chiu, S.-W., Takata, M. et al. (2020). Clinical trial monitoring effectiveness: remote risk-based monitoring versus on-site monitoring with 100% source data verification. Clinical Trials, 18(2), 158-167. https://doi.org/10.1177/1740774520971.
Rosenberg, L., Levaux, H., Levine, R. L., Shah, A., Denmark, J., Hereema, N., Owen, M., Kalk, S., Kenny, N., Vinson, G., Vergilio, J. A., Mims, A., Borate, U., Blum, W., Stein, E., Gana, T. J., Stefanos, M., Yocum, A., Marcus, S., Shoben, A., Druker, B., & Byrd, J. (2021). Streamlined operational approaches and use of e-technologies in clinical trials: Beat acute myeloid leukemia master trial. Therapeutic Innovation and Regulatory Science, 55(5), 926-935. https://doi.org/10.1007/s43441-021-00277-w.
Tantsyura, V., Dunn, I. M., Waters, J. et al. (2016). Extended risk-based monitoring model, on-demand query-driven source data verification, and their economic impact on clinical trial operations. Therapeutic Innovation and Regulatory Science, 50(1), 115–122. https://doi.org/10.1177/2168479015596020.
Li, P., Lei, H., Zhang, C., Rao, X., Huang, S., Cao, D., Zhou, J., & Wen, J. (2026). Development and application of a digital intelligent platform for clinical trial management. Intelligent Pharmacy, 4(1), 12-19. https://doi.org/10.1016/j.ipha.2025.09.002.
Sharma, A. (2016). eSource and risk-based monitoring. Clinical Researcher, June 2016. https://acrpnet.org/wp-content/uploads/dlm_uploads/2017/03/ACRP-Clinical-Researcher-June-2016.pdf.
Manasco, P. K. (June 1, 2016). Quality remote monitoring: the tools of the game. Applied Clinical Trials, 25(6). https://www.appliedclinicaltrialsonline.com/view/quality-remote-monitoring-tools-game.
Barnes, B., Stansbury, N., Brown, D., Garson, L., Gerard, G., Piccoli, N., Jendrasek, D., May, N., Castillo, V., Adelfio, A., Ramirez, N., McSweeney, A., Berlien, R., & Butler, P. J. (2021). Risk-based monitoring in clinical trials: past, present, and future. Therapeutic Innovation and Regulatory Science, 55(4), 899-906. https://doi.org/10.1007/s43441-021-00295-8.
U.S. Food and Drug Administration (August 7, 2013). Oversight of clinical investigations – A risk-based approach to monitoring: Guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (November 9, 2016). Integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Chaturvedi, P. R. (2016). Critical utility of e-solutions in risk based monitoring. International Journal of Clinical Trials, 3(4), 199-202. https://doi.org/10.18203/2349-3259.ijct20163957.
Agrafiotis, D. K. et al. (2018). Risk-based monitoring of clinical trials: An integrative approach. Clinical Therapeutics, 40(7), 1204-1212. https://doi.org/10.1016/j.clinthera.2018.04.020.
Hurley, C., Shiely, F., Power, J., Clarke, M., Eustace, J. A., Flanagan, E., & Kearney, P. M. (2016). Risk based monitoring (RBM) tools for clinical trials: A systematic review. Contemporary Clinical Trials, 51, 15-27. https://doi.org/10.1016/j.cct.2016.09.003.
Ehidiamen, A. J., & Oladapo, O. O. (2024). The role of electronic data capture systems in clinical trials: Streamlining data integrity and improving compliance with FDA and ICH/GCP guidelines. World Journal of Biology Pharmacy and Health Sciences, 20(1), 321-334. https://doi.org/10.30574/wjbphs.2024.20.1.0789.
Chandan, K. (2023). Advancing clinical data capture: embracing electronic data capture (EDC) for enhanced efficiency and quality. International Journal of Science and Research, 12(7), 1261-1264. https://doi.org/10.21275/SR23717190711.
Hirsch, I. B., Martinez, J., Dorsey, E. R., Finken, G., Fleming, A., Gropp, C., Home, P., Kaufer, D. I., & Papapetropoulos, S. (2017). Incorporating site-less clinical trials into drug development: A framework for action. Clinical Therapeutics, 39(5), 1064-1076. https://doi.org/10.1016/j.clinthera.2017.03.018.
Raja, S. (2023). Digital tools in decentralized clinical trials: eConsent, electronic data capture, ePRO, and related technologies. International Scientific Journal of Engineering and Management, 2(10), 1-6. https://doi.org/10.55041/ISJEM01272.
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. (January 6, 2025). Guideline for Good Clinical Practice E6(R3). https://database.ich.org/sites/default/files/ICH_E6%28R3%29_Step4_FinalGuideline_2025_0106.pdf
Uriti, S. (2024). Chapter 16. Computers in clinical development: clinical data collection and management. (2024). In Computer Aided Drug Development (pp. 426-458). ThinkPlus Pharma Publications. https://doi.org/10.69613/3gxqxw38.
Stafford, P. B., & Garrett, A. (2011). Using real-time data to drive better decisions, faster. Therapeutic Innovation and Regulatory Science, 45(4), 495-502. https://doi.org/10.1177/009286151104500410.
Zhang, J., Sun, L., Liu, Y., Wang, H., Sun, N., & Zhang, P. (2017). Mobile device-based electronic data capture system used in a clinical randomized controlled trial: advantages and challenges. Journal of Medical Internet Research, 19(3), e66. https://doi.org/10.2196/jmir.6978.
Daher, A., et al. (2023). A code for clinical trials centralized monitoring, sharing open-science solutions to high-quality data. PLOS ONE, 18(11). https://doi.org/10.1371/journal.pone.0294412.
Barnes, S., Katta, N., Sanford, N., et al. (2014). Technology considerations to enable the risk-based monitoring methodology. Therapeutic Innovations & Regulatory Science, 48(5), 536-545. https://doi.org/10.1177/2168479014546336.
Kommaraju, R. J. (2025). Optimizing data quality and compliance through integrated validation strategies for clinical systems. The American Journal of Engineering and Technology, 7(8), 299-306. https://doi.org/10.37547/tajet/Volume07Issue08-26.
Sahoo, U., & Bhatt, A. (2004). Electronic data capture (EDC) – A new mantra for clinical trials. Quality Assurance, 10(3-4), 117-121. https://doi.org/10.1080/10529410390892052.
Paul, S. (2024). Data integrity and quality in clinical trials. Revista de Inteligencia Artificial en Medicina, 15(1). https://redcrevistas.com/index.php/Revista/article/view/266.
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