Dynamic Dossier in the Cloud: A Sociotechnical Architecture for a Real-Time and Metrics-Based Data Tracking System with Gene and Cell Therapies as a Case Study.

Background: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient.

Methods: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing.

Results: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies.