Artificial Intelligence in Clinical Trial Design: FDA Expectations for Patient Stratification & Predictive Modeling
Date: May 22, 2026
Duration: 60 Minutes
Time: 12 PM EST
Artificial Intelligence (AI) is rapidly transforming clinical trial design—from improving patient stratification to enabling predictive modeling that enhances trial efficiency and outcomes. With the latest FDA guidance and guiding principles on AI in drug development, regulators are signaling a clear shift toward structured, risk-based adoption of AI across the clinical lifecycle.
This webinar will provide a practical roadmap for sponsors, CROs, and clinical teams to understand and operationalize AI within trial design—while staying aligned with evolving regulatory expectations. The webinar will help to leverage AI to reduce sample sizes, identify “super-responders,” and accelerate the path to approval without compromising data integrity. Attendees will gain insights into the application of AI for patient stratification and predictive modeling, including how these tools can support better decision-making and trial outcomes.
The session will also break down key elements of the new guidance, including defining context of use, ensuring data integrity, and maintaining ongoing model performance. Through real-world considerations and best practices, participants will learn how to balance innovation with compliance. Whether you are initiating a new trial or optimizing an existing one, this webinar will equip you with the knowledge needed to confidently navigate AI adoption in the 2026 regulatory landscape.
Learning Objectives
By the end of this session, participants will be able to:
- Understand how AI is being applied in patient stratification and predictive modeling
- Interpret key expectations from the Latest FDA guidance
- Apply risk-based validation and credibility frameworks to AI models
- Integrate AI into trial design while ensuring regulatory compliance and patient safety
- Identify common pitfalls and best practices for AI-driven trials
Topics to be Covered:
- The Growing Role of AI in Trial Design
- What the Latest FDA Guidance Signals
- AI in Patient Stratification
- AI in Predictive Modeling
- Practical Implementation Framework for Using AI in Trial Design
- Challenges and Risks of Using AI in Trial Design
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
Payment
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.
