Blockchain for Secure and Transparent Clinical Trial Data Management

DOI: https://doi.org/10.63345/ijrmp.org.v10.i6.2

Komal Barve

Independent Researcher

Nashik, Maharashtra, India

Abstract

The rapid evolution of clinical research demands data management systems that guarantee security, transparency, and integrity. This manuscript explores the role of blockchain technology in enhancing the management of clinical trial data. By leveraging the distributed ledger’s decentralized architecture, immutable records, and smart contracts, blockchain presents a viable solution to the data discrepancies and manipulation challenges currently faced in clinical trials. This study reviews historical developments and literature up to 2020, presents a statistical analysis comparing traditional and blockchain-based systems, and proposes a detailed methodology for implementing blockchain solutions in clinical trial environments. The results indicate significant improvements in data integrity, traceability, and stakeholder trust. The manuscript concludes by discussing the broader impact of blockchain adoption in clinical research, along with its scope and limitations.

Keywords

Blockchain, Clinical Trials, Data Management, Transparency, Security, Smart Contracts, Data Integrity

References

• https://www.google.com/url?sa=i&url=https%3A%2F%2Fimagecorelab.com%2Fthe-importance-of-data-management-in-clinical-trials%2F&psig=AOvVaw0KGKfGgx-qhh7ppnXGDH10&ust=1741200169160000&source=images&cd=vfe&opi=89978449&ved=0CBQQjRxqFwoTCIiRwKGK8YsDFQAAAAAdAAAAABAE
• https://www.google.com/url?sa=i&url=https%3A%2F%2Fwww.turing.com%2Fresources%2Fblockchain-for-healthcare&psig=AOvVaw03JnyxEk0MFrm-45loUqQL&ust=1741200303733000&source=images&cd=vfe&opi=89978449&ved=0CBQQjRxqFwoTCOjxkISL8YsDFQAAAAAdAAAAABAK
• Nakamoto, S. (2008). Bitcoin: A Peer-to-Peer Electronic Cash System.
• Crosby, M., Pattanayak, P., Verma, S., & Kalyanaraman, V. (2016). Blockchain technology: Beyond bitcoin. Applied Innovation Review, 2, 6–10.
• Agbo, C. C., Mahmoud, Q. H., & Eklund, J. M. (2019). Blockchain technology in healthcare: A comprehensive review and directions for future research. Applied Sciences, 9(18), 3612.
• Zhang, P., White, J., Schmidt, D. C., Lenz, G., & Rosenbloom, S. T. (2018). Applying software patterns to address interoperability in blockchain-based healthcare apps. Advances in Computers, 110, 127–160.
• Engelhardt, M. A. (2017). Hitching healthcare to the chain: An introduction to blockchain technology in the healthcare sector. Technology Innovation Management Review, 7(10), 22–34.
• Kuo, T. T., Kim, H. E., & Ohno-Machado, L. (2017). Blockchain distributed ledger technologies for biomedical and health care applications. Journal of the American Medical Informatics Association, 24(6), 1211–1220.
• Roehrs, A., da Costa, C. A., da Rosa Righi, R., & de Oliveira, K. S. F. (2017). OmniPHR: A distributed architecture model to integrate personal health records. Journal of Biomedical Informatics, 71, 70–81.
• Mackey, T. K., & Nayyar, G. (2016). A review of existing and emerging digital technologies to combat the global trade in fake medicines. Expert Opinion on Drug Safety, 15(5), 599–611.
• Dubovitskaya, A., Xu, Z., Ruf, B., & Schumacher, M. (2018). Secure and trustable electronic medical records sharing using blockchain. In 2018 IEEE International Conference on Internet of Things (iThings) and IEEE Green Computing and Communications (GreenCom) and IEEE Cyber, Physical and Social Computing (CPSCom) and IEEE Smart Data (SmartData) (pp. 289–296). IEEE.
• Wang, Y., Kung, L. A., & Byrd, T. A. (2018). Big data analytics: Understanding its capabilities and potential benefits for healthcare organizations. Technological Forecasting and Social Change, 126, 3–13.
• Mettler, M. (2016). Blockchain technology in healthcare: The revolution starts here. In 2016 IEEE 18th International Conference on e-Health Networking, Applications and Services (Healthcom) (pp. 1–3). IEEE.
• Esposito, C., De Santis, A., Tortora, G., Chang, H., & Choo, K.-K. R. (2018). Blockchain: A panacea for healthcare cloud-based data security and privacy? IEEE Cloud Computing, 5(1), 31–37.
• Zhang, R., & White, J. (2017). Applied blockchain: A new approach to structuring electronic health records. In IEEE Conference on Healthcare Informatics (pp. 1–5). IEEE.
• Beck, R., Avital, M., Rossi, M., & Thatcher, S. M. (2016). Blockchain technology in business and information systems research. Business & Information Systems Engineering, 58(2), 93–94.
• Azaria, A., Ekblaw, A., Vieira, T., & Lippman, A. (2016). MedRec: Using blockchain for medical data access and permission management. In 2016 2nd International Conference on Open and Big Data (OBD) (pp. 25–30). IEEE.
• Liu, Y., & Zhang, Y. (2017). Security and privacy in mobile health (mHealth) systems: A systematic review. IEEE Access, 5, 12937–12951.
• Suk, J., & Lee, J. (2018). Blockchain-based distributed healthcare system using smart contracts: A review. Journal of Healthcare Engineering, 2018, 1–8.
• Yli-Huumo, J., Ko, D., Choi, S., Park, S., & Smolander, K. (2016). Where is current research on blockchain technology? A systematic review. PLoS ONE, 11(10), e0163477.
• Bocek, T., Rodrigues, B. B., Strasser, T., & Stiller, B. (2017). Blockchains everywhere—a use-case of blockchains in the pharma supply-chain. In 2017 1st International Workshop on Blockchains and Smart Contracts for Distributed Systems (BSCDS) (pp. 1–6). IEEE.
• Patel, V., & Patel, N. (2019). Blockchain in clinical trial management: A review of current trends and future directions. Journal of Clinical Trials, 9(3), 95–104.