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Courtesy of TriNetX Experts
1. Precision by Numbers: Data-Driven Clinical Trials
The Forecast
Clinical trials are being reinvented by real-world data (RWD). In 2025, data-driven strategies won’t just complement trial design—they’ll define it. From protocol optimization to accelerated site identification, data is the new compass guiding clinical innovation.
Why it Matters
- Precision fuels performance: Real-time and historical data contribute to highly targeted, efficient protocols.
- Smart selection: AI-powered analytics help to pinpoint ideal sites, investigators, and participants—cutting costs and timelines.
- Predictive insights: RWD helps to identify enrollment risks and enhances participant diversity while reducing dropouts.
Precision in Practice
A leading contract research organization (CRO) used TriNetX to automate site identification and outreach, replacing manual processes with data-driven strategies. Within 90 days, the CRO increased site engagement, expanded principal investigator (PI) outreach, and completed more studies than in the previous year—all through data precision.
2. Equity by Design: Building Inclusive Research Frameworks
The Forecast
Despite recent regulatory shifts, the industry’s commitment to equity will remain strong. Organizations must navigate the evolving regulatory landscape while meeting the increasing public and scientific demands for inclusive, representative research.
Why it Matters
- Representative results: Diverse trials yield more accurate, universally applicable treatments.
- Trust through inclusion: Equitable research restores confidence in science among historically underserved populations.
- Global impact: Inclusion ensures solutions resonate across genetics, lifestyles, and geographies.
Equity in Practice
One TriNetX client leveraged RWD to revise eligibility criteria across 25 protocols, removing hidden barriers to diversity. The result: a 29% increase in participant representation—without compromising scientific rigor.
3. AI Meets RWD: Revolutionizing Drug Development and Research
The Forecast
Artificial intelligence (AI) will streamline drug development by accelerating hypothesis testing and reducing trial-and-error, helping bring therapies to market faster. Initiatives like Stargate AI highlight the growing national focus on integrating AI for greater efficiency and insight in RWD analysis.
Why it Matters
- Efficiency unlocked: AI and RWD slice through the labyrinth of clinical trials, automating data analysis to optimize timelines, resources, and dollars.
- Deeper insights: AI-enhanced RWD uncovers patterns and predictions traditional methods miss.
- Proactive decisions: AI forecasts outcomes, helping researchers pivot early and avoid costly detours.
AI/RWD in Practice
TriNetX built a machine learning model to flag inflammatory bowel disease (IBD) patients at risk of treatment escalation within 7 days. This innovative approach has the potential to significantly improve trial enrollment success rates, increasing clinical trial conversion from 33% to as high as 85% for Crohn’s disease (CD) and 70% for ulcerative colitis (UC).
4. Care Reimagined: Patient-Centricity from Trials to Treatments
The Forecast
Patient-centricity will drive everything—from trial design to long-term outcomes. Expect research protocols to increasingly mirror real-world patient experiences, with digital tools enabling more inclusive and accessible studies.
Why it Matters
- Patients first: Centering trials on patient realities ensures meaningful, relevant results.
- Reduced burden: Simplified protocols and digital tools enhance recruitment and retention.
- Stronger outcomes: Research aligned with patient priorities delivers tangible, real-world benefits.
Patient-Centricity in Practice
By using TriNetX RWD, researchers created a “digital waiting room” to monitor Lupus patients and flag those who met strict trial criteria. The result: 103 potential candidates identified, streamlining proactive and efficient recruitment.
5. Evidence in Action: RWE’s Role in Shaping Regulatory Innovation
The Forecast
Real-world evidence (RWE) is now a cornerstone of regulatory strategy. Agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) are embracing RWE to accelerate approvals, validate safety, and support label expansions. Transparent and high-quality RWD will be essential.
Why it Matters
- Regulatory momentum: RWE is influencing faster, more informed decision-making.
- Real-time readiness: Availability of up-to-the-minute RWD helps validate safety and efficacy on an ongoing basis.
- Access unlocked: RWE shortens the time from discovery to delivery for life-saving therapies.
RWE in Practice
TriNetX Oncology experts conducted an external cohort study using multiple myeloma RWD to analyze patients treated with cilta-cel, showing significantly better outcomes in overall survival and time to next treatment, highlighting its potential as a novel and effective treatment. These findings were used by TriNetX pharma partners to support health technology assessment (HTA) and regulatory submissions.
What Will You Do with the Power of RWD?
Explore the possibilities in The Future Prescription: Leveraging Real-World Data to Navigate 5 Key Shifts in Healthcare and Clinical Research. This essential TriNetX trends report is your roadmap to staying ahead of the curve—and shaping the future of healthcare in 2025 and beyond.
