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Can Synthetic Data Save Clinical Trials?

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Facing a recruitment crisis, clinical trials are turning to synthetic data as a solution. Discover how digital twins are helping researchers save studies, protect privacy, and accelerate medical breakthroughs.

The Recruitment Crisis in Clinical Trials

Running a clinical trial is no easy feat—especially when it comes to finding enough participants. Trials often fall short of recruitment goals, sometimes due to funding cuts or difficulty locating eligible patients. When that happens, studies can be shut down or altered, producing less meaningful results and wasting valuable time and resources.

Enter Synthetic Data: A Digital Lifeline

Dr. Khaled El Emam, a senior scientist at the CHEO Research Institute and Canada Research Chair in Medical AI at the University of Ottawa, is exploring a promising solution: synthetic data generation (SDG).

In his latest study—the largest of its kind—Dr. El Emam and his team recreated nine completed breast cancer trials by replacing a portion of human participants with synthetic “digital twins.” The trials included collaborations with The Ottawa Hospital Research Institute (OHRI).

Results That Mirror Reality

The findings were remarkable. When at least 60% of the participants were real people, synthetic data was able to closely replicate the original trial results.

“The simulation worked incredibly well,” said Dr. El Emam. “This gives us an option to continue research when recruitment targets fall short.”

The research shows synthetic data could serve as a reliable backup plan, helping studies stay on track even when participation numbers don’t.

Ethics, Efficiency, and the Future of Trials

For both ethical and scientific reasons, salvaging struggling trials is crucial. Synthetic data could offer a more responsible and efficient way to ensure studies yield results, without compromising patient privacy or scientific integrity.

Still, Dr. El Emam emphasizes the need for ongoing dialogue:

“We must bring researchers, clinicians, regulators, and patients into the conversation to build trust in this new tool.”

Scaling Up: 100 Trials and Counting

Working with OHRI’s REaCT program, Dr. El Emam’s team is preparing to simulate 100 clinical trials using synthetic data across various diseases, populations, and study sizes—taking the research to the next level.

Dr. Mark Clemons, a medical oncologist at The Ottawa Hospital, highlighted the goal:

“This research helps make clinical trials more efficient so better treatments reach patients sooner.”

Join the Conversation: Synthetic Data Summit 2025

To further the conversation, industry leaders, researchers, and policymakers will gather at the 2025 Synthetic Data Summit on May 16 at the PHI Centre in Montreal.

Hosted by the Electronic Health Information Laboratory at CHEO, the summit will explore how synthetic data is tackling real-world challenges—from privacy protection to bias reduction and research scalability.

“This is a chance to see how AI and synthetic data are shaping the future of health care,” said Dr. El Emam.

A New Era for Clinical Trials?

While it may not replace traditional methods, synthetic data is emerging as a powerful ally for researchers. With continued study and open collaboration, it could help ensure clinical trials deliver on their promise—even when obstacles arise.

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