Blockchain based clinical trial management system: A scoping review and conceptual framework

ObjectiveThe primary objective of the study was to map the real-world evidence of using Blockchain technology in clinical trial management systems and to create a novel conceptual framework for a Blockchain based digital ecosystem. As a first step towards validation of this conceptual framework, we aimed to create a blockchain simulation in Python programming language. MethodsWe did a scoping review of research articles which demonstrated a proof-of-concept or real-world application of Blockchain technology in clinical trial management. We searched in the PubMed, Web of Science, and IEEE Xplore to retrieve original articles published in English till April 2023. A novel conceptual framework was developed for a Blockchain based digital ecosystem with all the stakeholders involved in the conduct of clinical trial. We coded a simulation of clinical trial specific blockchain in Python using Django framework and the codes are made publicly available in GitHub. ResultsWe retrieved 960 abstracts and included 21 full text articles in the review. Private blockchains like Hyperledger fabric and Ethereum are the most popular choice of platform. Smart contracts act as a key functionality in the Blockchain system to control specific activities. Clinical trial data was mostly stored outside the Blockchain, but Interplanetary File System is a popular choice for decentralized storage of data. ConclusionsThe scoping review, conceptual framework and the open-source Python codes would act as a guiding map for future research and product development in Blockchain based clinical trial management system and advancement in clinical research informatics.