Part 3: Innovation in Clinical Research: AI-based Drug Development Tools and the Regulatory Landscape‍

Leveraging new technology is critical for accelerating progress in clinical research. In principal, novel drug development tools should undergo regulatory review to ensure validity and safety. An example of an AI-based drug development tool is a Digital Twin. Digital Twins, or AI-generated placebo outcomes created from patient baseline data in clinical trials, can be incorporated into trials to provide patient level insights and enable smaller, more efficient trials. Unlearn continues to work closely with regulators, industry experts, and drug sponsors to navigate a strategic path forward toward regulatory clarity for drug development tools like Digital Twins. Join Unlearn for a panel discussion of industry regulatory experts about the current regulatory landscape and how innovators can help shape the future of how AI is used and regulated in drug development.


  • Regulatory considerations for Digital Twins 
  • Current regulatory perspectives on AI and future trends 
  • Regulatory strategies for implementing innovative technology in clinical research

THIS WEBINAR IS PART #3 OF Powering Clinical Research with AI 

Clinical trials are critical for developing new treatments, but face chronic challenges, such as optimal trial design, enrollment, costs, timeline delays, and high failure rates. The gold standard of trial design is randomization, but it is not always ethical or feasible to set up a trial where the control group receives a standard of care or a placebo. Leveraging historical data sets and novel machine learning methods, Digital Twins, or statistically indistinguishable virtual placebo patients, can be generated to match actual patients in clinical studies. Adding external control arms populated with Digital Twins, called Intelligent Control Arms, can streamline clinical trials, increase power, and decrease enrollment, without adding regulatory risk. The FDA has expressed support for innovation in trial design and alternative forms of evidence - Digital Twins are the next frontier for modern trials.

In this 3 part webinar series, you will learn about: 

  • AI and Machine Learning 
  • Digital Twins, what they are and how they are created 
  • Specific use cases for Digital Twins 
  • Trial designs and statistical approaches to increase power and accelerate timelines 
  • The regulatory landscape and support behind solutions like Digital Twins

Who should attend? 

  • Biostatisticians and statisticians 
  • Business Development/Partnerships
  • Commercial Teams Data Science Medical Directors
  • Principal Investigators
  • Clinical Research Leads
  • Regulatory Affairs

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Why can’t we agree on how to define digital twins in healthcare?

White Papers

Summary of the EMA September 2022 Qualification Opinion for PROCOVA™


Charles Fisher, Unlearn.AI: “now is the time to adopt AI-based solutions”

The potential for AI implementation in healthcare can barely be measured, as it can already do what humans do, just countless times better and more efficiently.
The European Medicines Agency has qualified Unlearn’s AI-powered method for running smaller, faster clinical trials.
Digital twins seem to be everywhere in healthcare now, but no one agrees on a single definition for them.