Exploiting Ethereum Smart Contracts for Clinical Trial Management

Blockchain is a distributed ledger that ensures the authenticity of business transactions without the involvement of intermediaries, brokers or trusted third parties. The main features of blockchain technology include transparency, immutability and data provenance offers an important role in satisfying the requirements of a more secure, visible, efficient, and trusted clinical trial (CT) management. This is because the traditional CTs face significant challenges such as protocol compliance, transparency and patient enrollment. In this paper we discuss how blockchain technology can be leveraged to tackle data management challenges in clinical trials. We propose a blockchain-based framework using Ethereum based smart contract. In the framework, three stages of a CT process were captured: new drug application, CT initiation and patient enrollment stages. The framework captures key interactions among CT stakeholders including the regulatory agency, drug sponsor, principal investigator, physician and patients. The smart contract was written in Remix IDE and was successfully compiled and tested for different scenarios. The proposed approach and results can be highly beneficial to various stakeholders in CT data management.