The Joint eCF/Eucroff "Artificial Intelligence and Machine Learning" Task Force is pleased to announce the public release of their position paper entitled "AI state-of-play around clinical research"

This position paper provides information about the state-of-play of artificial intelligence (AI) and machine learning (ML) for clinical research.

The regulatory overview presented in this paper shows that while regulations are far from final for all use cases, the US and Europe have made the biggest steps toward monitoring and facilitating the use of AI, and regulations are in development in other regions around the globe.

Use cases presented include AI to enhance clinical trial operations, feasibility exploration according to inclusion/exclusion criteria for recruitment, patient and site recruitment, applications to improve trial operations, risk-based monitoring and data management, task automation, applications for Real World Evidence (RWE), medical coding, and more.

The paper presents clinical evaluation challenges for the development and validation of AI, focusing on data acquisition and selection, AI modelling, change management, and monitoring and evaluating trends.       

The paper offers the UK Information Commissioner’s Office (ICO) toolkit for AI risk mitigation as a best practice for compliance and the basis of validation.

The paper concludes with the positions of the AI Task Force, including the promise for improving treatments and clinical research, the risks, and the challenge for using AI given the current state of evolving regulations.