Blockchain-based solutions for clinical trial data management: a systematic review
DOI:
https://doi.org/10.56294/mr202217Keywords:
Blockchain, Blockchain Technology, Clinical TrialsAbstract
Blockchain technology can reduce the need for intermediaries in various types of transactions by providing a decentralized and secure ledger that can be accessed and updated by all parties involved in the transaction. Clinical trials are essential for bringing new drugs and therapies to market, but the current clinical research process is often marred by inefficiencies, data inaccuracies, and a lack of transparency. The implementation of blockchain technology in clinical trials has the potential to address these challenges by providing a secure and transparent platform for data management. By leveraging the power of blockchain, healthcare providers can improve the integrity and accuracy of clinical trial data, enhance trust in the clinical research process, and ultimately improve patient outcomes. In this article, we propose the use of blockchain technology in clinical trials and explore its potential benefits for the healthcare. The implementation of a blockchain-based data management system for clinical trials holds significant potential to address several challenges associated with the current clinical research process. By improving the integrity and security of medical data, enhancing trust, and easing regulatory burden, such a system can promote the efficient and effective conduct of clinical trials. The adoption of a blockchain-based solution for clinical trial data management has the potential to optimize costs, contributing to the sustainability of healthcare services. It also provides a model for future research and development of blockchain-based solutions in the field of clinical research.
References
1. Nofer M, Gomber P, Hinz O, Schiereck D. Blockchain. Bus Inf Syst Eng 2017;59:183–7. https://doi.org/10.1007/s12599-017-0467-3.
2. Xu M, Chen X, Kou G. A systematic review of blockchain. Financ Innov 2019;5:27. https://doi.org/10.1186/s40854-019-0147-z.
3. Dal-Ré R. Improving transparency of clinical trials. Trends in Pharmacological Sciences 2015;36:323–5. https://doi.org/10.1016/j.tips.2014.10.012.
4. Hang L, Kim B, Kim K, Kim D. A Permissioned Blockchain-Based Clinical Trial Service Platform to Improve Trial Data Transparency. Biomed Res Int 2021;2021:5554487. https://doi.org/10.1155/2021/5554487.
5. Benchoufi M, Porcher R, Ravaud P. Blockchain protocols in clinical trials: Transparency and traceability of consent. F1000Res 2017;6:66. https://doi.org/10.12688/f1000research.10531.5.
6. Benchoufi M, Ravaud P. Blockchain technology for improving clinical research quality. Trials 2017;18:335. https://doi.org/10.1186/s13063-017-2035-z.
7. Fatoum H, Hanna S, Halamka JD, Sicker DC, Spangenberg P, Hashmi SK. Blockchain Integration With Digital Technology and the Future of Health Care Ecosystems: Systematic Review. J Med Internet Res 2021;23:e19846. https://doi.org/10.2196/19846.
8. Gonzales A, Smith SR, Dullabh P, Hovey L, Heaney-Huls K, Robichaud M, et al. Potential Uses of Blockchain Technology for Outcomes Research on Opioids. JMIR Med Inform 2021;9:e16293. https://doi.org/10.2196/16293.
9. Hameed K, Bajwa IS, Sarwar N, Anwar W, Mushtaq Z, Rashid T. Integration of 5G and Block-Chain Technologies in Smart Telemedicine Using IoT. J Healthc Eng 2021;2021:8814364. https://doi.org/10.1155/2021/8814364.
10. Hirano T, Motohashi T, Okumura K, Takajo K, Kuroki T, Ichikawa D, et al. Data Validation and Verification Using Blockchain in a Clinical Trial for Breast Cancer: Regulatory Sandbox. J Med Internet Res 2020;22:e18938. https://doi.org/10.2196/18938.
11. Huh KY, Jeong S-U, Moon SJ, Kim M-J, Yang W, Jeong M, et al. METORY: Development of a Demand-Driven Blockchain-Based Dynamic Consent Platform Tailored for Clinical Trials. Front Med (Lausanne) 2022;9:837197. https://doi.org/10.3389/fmed.2022.837197.
12. Jeng W, Wang S-H, Chen H-W, Huang P-W, Chen Y-J, Hsiao H-C. A decentralized framework for cultivating research lifecycle transparency. PLoS One 2020;15:e0241496. https://doi.org/10.1371/journal.pone.0241496.
13. Joda T, Waltimo T, Probst-Hensch N, Pauli-Magnus C, Zitzmann NU. Health Data in Dentistry: An Attempt to Master the Digital Challenge. Public Health Genomics 2019;22:1–7. https://doi.org/10.1159/000501643.
14. Jung SY, Kim T, Hwang HJ, Hong K. Mechanism Design of Health Care Blockchain System Token Economy: Development Study Based on Simulated Real-World Scenarios. J Med Internet Res 2021;23:e26802. https://doi.org/10.2196/26802.
15. Macdonald JC, Isom DC, Evans DD, Page KJ. Digital Innovation in Medicinal Product Regulatory Submission, Review, and Approvals to Create a Dynamic Regulatory Ecosystem-Are We Ready for a Revolution? Front Med (Lausanne) 2021;8:660808. https://doi.org/10.3389/fmed.2021.660808.
16. Maslove DM, Klein J, Brohman K, Martin P. Using Blockchain Technology to Manage Clinical Trials Data: A Proof-of-Concept Study. JMIR Med Inform 2018;6:e11949. https://doi.org/10.2196/11949.
17. Motohashi T, Hirano T, Okumura K, Kashiyama M, Ichikawa D, Ueno T. Secure and Scalable mHealth Data Management Using Blockchain Combined With Client Hashchain: System Design and Validation. J Med Internet Res 2019;21:e13385. https://doi.org/10.2196/13385.
18. Qiao R, Luo X-Y, Zhu S-F, Liu A-D, Yan X-Q, Wang Q-X. Dynamic Autonomous Cross Consortium Chain Mechanism in e-Healthcare. IEEE J Biomed Health Inform 2020;24:2157–68. https://doi.org/10.1109/JBHI.2019.2963437.
19. Zhuang Y, Chen Y-W, Shae Z-Y, Shyu C-R. Generalizable Layered Blockchain Architecture for Health Care Applications: Development, Case Studies, and Evaluation. J Med Internet Res 2020;22:e19029. https://doi.org/10.2196/19029.
20. Charles WM. Accelerating Life Sciences Research with Blockchain. In: Namasudra S, Deka GC, editors. Applications of Blockchain in Healthcare, Singapore: Springer; 2021, p. 221–52. https://doi.org/10.1007/978-981-15-9547-9_9.
21. Bittins S, Kober G, Margheri A, Masi M, Miladi A, Sassone V. Healthcare Data Management by Using Blockchain Technology. In: Namasudra S, Deka GC, editors. Applications of Blockchain in Healthcare, Singapore: Springer; 2021, p. 1–27. https://doi.org/10.1007/978-981-15-9547-9_1.
22. Namasudra S, Deka GC, editors. Applications of Blockchain in Healthcare. vol. 83. Singapore: Springer; 2021. https://doi.org/10.1007/978-981-15-9547-9.
23. Wüst K, Gervais A. Do you Need a Blockchain? 2018 Crypto Valley Conference on Blockchain Technology (CVCBT), 2018, p. 45–54. https://doi.org/10.1109/CVCBT.2018.00011.
24. Koens T, Poll E. What Blockchain Alternative Do You Need? In: Garcia-Alfaro J, Herrera-Joancomartí J, Livraga G, Rios R, editors. Data Privacy Management, Cryptocurrencies and Blockchain Technology, Cham: Springer International Publishing; 2018, p. 113–29. https://doi.org/10.1007/978-3-030-00305-0_9.
25. Hasselgren A, Kralevska K, Gligoroski D, Pedersen SA, Faxvaag A. Blockchain in healthcare and health sciences—A scoping review. International Journal of Medical Informatics 2020;134:104040. https://doi.org/10.1016/j.ijmedinf.2019.104040.
26. Hölbl M, Kompara M, Kamišalić A, Nemec Zlatolas L. A Systematic Review of the Use of Blockchain in Healthcare. Symmetry 2018;10:470. https://doi.org/10.3390/sym10100470.
27. McGhin T, Choo K-KR, Liu CZ, He D. Blockchain in healthcare applications: Research challenges and opportunities. Journal of Network and Computer Applications 2019;135:62–75. https://doi.org/10.1016/j.jnca.2019.02.027.
28. Prokofieva M, Miah SJ. Blockchain in healthcare. Australasian Journal of Information Systems 2019;23. https://doi.org/10.3127/ajis.v23i0.2203.
29. Gatteschi V, Lamberti F, Demartini C, Pranteda C, Santamaría V. To Blockchain or Not to Blockchain: That Is the Question. IT Professional 2018;20:62–74. https://doi.org/10.1109/MITP.2018.021921652.
30. Chen HS, Jarrell JT, Carpenter KA, Cohen DS, Huang X. Blockchain in Healthcare: A Patient-Centered Model. Biomed J Sci Tech Res 2019;20:15017–22.
31. Bell L, Buchanan WJ, Cameron J, Lo O. Applications of Blockchain Within Healthcare. Blockchain in Healthcare Today 2018.
32. Ismail L, Materwala H, Zeadally S. Lightweight Blockchain for Healthcare. IEEE Access 2019;7:149935–51. https://doi.org/10.1109/ACCESS.2019.2947613.
33. Fusco A, Dicuonzo G, Dell’Atti V, Tatullo M. Blockchain in Healthcare: Insights on COVID-19. International Journal of Environmental Research and Public Health 2020;17:7167. https://doi.org/10.3390/ijerph17197167.
34. Ciampi M, Esposito A, Marangio F, Sicuranza M, Schmid G. Modernizing Healthcare by Using Blockchain. In: Namasudra S, Deka GC, editors. Applications of Blockchain in Healthcare, Singapore: Springer; 2021, p. 29–67. https://doi.org/10.1007/978-981-15-9547-9_2.
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