BLOCKCHAIN-ENABLED SAFETY MANAGEMENT ARCHITECTURE FOR CLINICAL TRIALS

Clinical trial participants are a vital part of drug development research and there are many rules to help and ensure the safety and ethics of clinical trials. Managing patient safety during clinical trials is a critical component throughout the drug development life-cycle. As the first step towards ensuring patient safety, all the involved parties in drug development need to be respectful and responsive towards patient’s needs, comfort, and preferences i.e. ensuring a patient-centric approach. In this paper blockchain technology is embedded in the Quality by Design (QbD) systematic approach to boost data integrity among the activities, and to promote participants’ safety in clinical trials. First, blockchain-enabled QbD architecture is proposed and the interactions among the enablers and peers are highlighted. Then, a prototype of the proposed architecture is developed and the data of a pilot trial is used to justify the applicability of the architecture. The results showed that the proposed architecture is efficient, and hence it is feasible to adopt into a clinical trial.