A Double-Blind Trial Platform Based on Distributed Ledger Technology

Abstract

In the pharmaceutical research and development process, the third phase of clinical trials involves double-blind trials to mitigate the influence of human subjective awareness on the experimental results and ensure the efficacy and safety of drugs or vaccines. However, conventional double-blind trials are often overseen by a single institution responsible for the entire trial process. Researchers centrally manage data, introducing risks of data loss and tampering. Furthermore, since researchers have full access to all experimental data, there is a potential for premature unblinding and leakage of results to specific individuals, giving rise to bias and conflicts of interest. To address these problems, this paper proposes a distributed-ledger-based double-blind trial platform called “BlindBox”. This platform leverages the immutability and decentralization of distributed ledgers to enhance the security of experimental data. On the other hand, the platform employs smart contracts to restrict personnel’s access to experimental data, coupled with RFID technology to encode and shuffle the experimental drugs discreetly. This ensures that no one can ascertain the pairing between test subjects and drug groups, preventing collusion and result manipulation. When the trial period concludes, smart contracts automatically unblind the results and publish them on the IOTA platform. By utilizing IOTA’s zero-value transactions, the platform reduces the cost of repeated data access and ensures information openness and transparency. This approach prevents deliberate premature unblinding or insider trading stemming from monopolized information. The platform proposed in this study is expected to enhance the credibility and accuracy of double-blind trials while promoting the willingness and convenience of public participation in experiments.