Data science and digital health in clinical development and operations: impact, challenges, and calls to action for the drug development ecosystem
In this paper, the Medicines Development Modernization Initiative discuss how three medicines development tools (MDTs) – artificial intelligence (AI) and machine learning (ML) algorithms, digital health tools (DHTs), and augmentation of randomized controlled trial (RCT) data with real-world data (RWD) – can be applied to transform clinical development. The use cases discussed in the upcoming sections illustrate how novel MDTs can help redefine how the biopharmaceutical research sector conducts clinical study design and operations, resulting in tangible impact across a broad set of stakeholders in the healthcare ecosystem. They also highlight outstanding challenges to realize the full potential of MDTs in clinical development and the considerable opportunity that exists to modernize medicines development further. Integrating MDTs in an ecosystem that recognizes and supports the public health benefits of innovation will generate better medicines for patients while reducing the time and cost of development – allowing the best medicines to reach patients in need sooner.