ICH-GCP, AI (Artificial Intelligence), and Machine Learning: The Future of Drug Development
Introduction Clinical trials play a critical role in the development of new drugs, but they are often associated with inflated costs, long durations, and low success rates. However, the advancement of Artificial Intelligence (AI) and Machine Learning (ML) may be able to mitigate these challenges. This blog post explores how the International Council for Harmonisation and Good Clinical Practice (ICH-GCP) guidelines safeguard the safety and well-being of trial subjects and data integrity in the era of AI/ML Trial Design Let’s start with the most crucial part —the trial design. It’s possible for AI/ML to actually generate trial protocols! However, it’s important to ensure that these protocols follow all the rules […]