Blockchain can secure clinical trial data by providing an immutable ledger that enhances data integrity and transparency among stakeholders. This ledger allows for tamper-evident record-keeping, ensuring that once data are written, they cannot be altered without detection, thus strengthening audit trails in clinical research[4]. Furthermore, blockchain streamlines patient consent tracking and data sharing across various parties, empowering patients to control their data permissions while ensuring compliance with ethical standards[5].
However, the scalability of blockchain solutions presents challenges, particularly with transaction throughput and data management in large clinical trials[5]. Ongoing pilot projects, such as BlockTrial, showcase the feasibility of blockchain applications in managing clinical trial processes and ensuring compliance with regulatory requirements[3].
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