NEW YORK, Aug. 13, 2025 /PRNewswire/ — HopeAI , a Mayo Clinic Platform Accelerate company, is advancing how cancer clinical trials are designed and executed. At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, HopeAI presented new results demonstrating how AI-generated synthetic individual patient data ( SynthIPD ) can accelerate regulatory-grade evidence generation — without the need for real patient-level data.
Drug development faces a long-standing challenge: pivotal oncology trials often require years of patient follow-up to assess survival outcomes, delaying both regulatory decisions and patient access. Validating surrogate endpoints, such as minimal residual disease (MRD) negativity, offers a proven path to accelerate approvals — but conventional validation methods rely on time-intensive meta-analyses and multi-institutional data sharing, often taking 1–2 years to complete.
Key Highlights from the ASCO Presentation
- AI-Enabled Surrogacy Validation: HopeAI’s agentic AI workflow, combined with expert statistical curation, enables rapid trial-level and patient-level surrogacy analyses using up-to-date evidence.
- Synthetic Individual Patient Data ( SynthIPD ): By digitizing Kaplan–Meier plots from published studies, SynthIPD reconstructs individual patient time-to-event and covariate data with high statistical fidelity to original datasets.
- Demonstrated Impact in Multiple Myeloma: The analysis confirmed a moderate surrogacy relationship between MRD negativity and progression-free survival (PFS) across recent myeloma trials, supporting its utility as a regulatory endpoint.
- Speed and Efficiency: Compared to traditional pooled analyses taking up to 24 months, HopeAI’s AI + expert-in-the-loop approach completed the process in under two weeks.
Why This Matters for the Market
- Shorter Path to Market: Enabling surrogate endpoint validation in weeks instead of years can accelerate drug approvals, improving pipeline value and reducing late-stage attrition risk.
- Regulatory-Ready Evidence: AI-powered workflows deliver analyses aligned with regulatory expectations, supporting NDA/BLA submissions and label expansions.
- Commercial Validation: HopeAI’s platforms are already in use with world’s top pharmaceutical companies and multiple biotech innovators.
- Strategic Differentiator: Access to Mayo Clinic’s real-world data and clinical expertise provides a competitive advantage in both evidence quality and time-to-insight.
About HopeAI
HopeAI is to bring hope to patients by accelerating the clinical development of new treatments through the power of AI. By integrating comprehensive clinical evidence with cutting-edge statistical innovation, HopeAI facilitates optimized clinical trial design, improves patient recruitment, enhances real-world, evidence-based decision-making, synthesizes data-driven support, and increases the probability of success in clinical development. For more information about HopeAI and its AI-driven solutions, visit https://hopeai.co/
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SOURCE HopeAI, Inc.
