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Artificial Intelligence (AI) and Clinical Research

Artificial intelligence (AI) in clinical research is being deployed across all aspects of research, both as an experimental intervention, and as an ancillary tool to support the administration of research and optimize trial design, planning, recruitment, and analysis. The MRCT Center established this project to explore the actionable, practical, and ethical considerations when using artificial intelligence (AI) in clinical research. As with all research involving human participants, effective and efficient use of AI in clinical research should be grounded in existing ethical principles and governing regulations to protect participants.

In 2024, the MRCT Center, in collaboration with WCG Clinical, convened a multidisciplinary task force to develop resources to address ethical and regulatory challenges during the IRB review of clinical research involving AI as the experimental intervention. In 2025, the task force publicly launched the Framework for Review of Clinical Research Involving Artificial Intelligence.

In 2026, the MRCT Center and WCG Clinical task force expanded its membership and focus to developing actionable, practical deliverables for the use of AI in the administration of clinical research.

This new project direction examines the use of AI in areas such as protocol development, trial modeling, site selection, participant recruitment and outreach, data collection and management, statistical analysis, and post-marketing requirements and aims to develop stakeholder responsibilities and guidance on responsible oversight, institutional responsibilities, and best practices for monitoring of AI systems.

In 2025, the MRCT Center also launched a webinar series on the use of digital twins and synthetic data to create virtual simulations of patient outcomes and how these approaches aim to improve the efficiency of clinical trials. The MRCT Center continues to work to evaluate the technical, ethical, and practical considerations involved with the use of digital twins and synthetic data.

OBJECTIVES

  • Define and analyze the current critical ethical and regulatory challenges of deploying AI across the clinical research lifecycle.
  • Discuss and develop practical and actionable resources to strengthen the capacity of IRBs, sponsors, and investigators to protect participants in research as AI’s role continues to grow.
  • Identify new resources and tools needed by stakeholders in the clinical research ecosystem.

KeY MILESTONES

  • February 2026: Convened the first meeting of the MRCT Center and WCG Clinical task force on the use of AI in the Administration of Research.
  • November 2025: Held a webinar in the AI Digital Twins and Synthetic Data series on Practical Use Cases in Clinical Research.
  • October 2025: Organized a panel during the MRCT Center’s Annual Symposium on the opportunities and challenges posed by the integration of AI in the informed consent process.
  • September 2025: Launched the first webinar in a series on AI Digital Twins and Synthetic Data: Practical Use Cases for Clinical Research
  • June 2025: Held a webinar to launch the Framework for Review of Clinical Research Involving Artificial Intelligence
  • November 2024: Organized a panel session during the MRCT Center’s Annual Symposium on Expanding the Uses of Data and AI in Support of Clinical Trials, beginning the Digital Twins and Synthetic Data workstream.
  • March 2024: Convened the first meeting of subject matter experts, including representation from academic medical centers and universities, industry, AI technologists, and IRB ethicists, members, and chairs.

project Leadership & sTAFF

  • Barbara Bierer, MD, Faculty Director, MRCT Center
  • Donna Snyder, MD, MBE, Executive Physician, WCG Clinical
  • Trevor Baker, MS, Program Manager, MRCT Center
  • Olchey Tchavyntchak, Research Assistant, MRCT Center

Project Resources