Introduction: The Digital Virtuous Loop

igital health data technology is transforming clinical research and therapeutic product development from a straight-line model (with data flowing “from beginning to end” to inform sequential, gated phases) to a self-reinforcing feedback loop–a digital virtuous loop that informs the entire product development lifecycle in an iterative manner.

For example:

  • Clinicians, regulators, and industry mine digital patient data and seek patient feedback to design clinical trials for new drug, device, or combination therapies that better meet the individual patient’s most pressing needs for their specific conditions.
  • Data analysts use artificial intelligence (AI), natural language processing (NLP), and machine learning (ML) to mine electronic health records, databases, or other real-world data to identify signals that inform the design of more relevant clinical trials with better-defined patient populations, and product labels that are patient-relevant and accessible.
  • Industry communicates with health technology assessment, reimbursement, payment, or related groups to leverage digital RWD/RWE and design clinical trials that better support reimbursement/payment decisions.

This special issue of Global Forum explores the contributions of digital sensors, artificial intelligence, real-world data, cloud technology, and other sections of this digital virtuous loop into the emerging modern model for global therapeutic product development, assessment, and patient access.