Towards reliable and transparent vaccine phase III trials with smart contracts

TL;DR

This paper proposes VaccSC, a blockchain-based protocol using smart contracts to enhance transparency, security, and auditability in vaccine Phase III clinical trials, addressing data integrity issues.

Contribution

The paper introduces VaccSC, a novel smart contract protocol that improves transparency and data integrity in vaccine trials, with implementation demonstrating key security features.

Findings

Enables double-blindness and randomization in trials

Provides auditability of clinical data

Maintains confidentiality even with dishonest participants

Abstract

Transforming a vaccine concept into a real vaccine product is a complicated process and includes finding suitable antigens and regulatory, technical, and manufacturing obstacles. A relevant issue within this scope is the clinical trial process. Monitoring and ensuring the integrity of trial data using the traditional system is not always feasible. The search for a vaccine against the coronavirus SARS-CoV-2 illustrates this situation. The scientific credibility of findings from several vaccines' clinical trials contributed to distorted perceptions concerning the benefits and risks of the drug. This scenario is ideal for applying technologies such as Blockchain and Smart Contracts in healthcare issues. This paper proposes a protocol based on Smart Contracts, named VaccSC, to enable transparency, accounting, and confidentiality to Phase III of vaccine experiments. The protocol was implemented in Solidity language, and results show that the VaccSC enables double-blindness, randomization, and the auditability of clinical data, even in the presence of dishonest participants.