SOURCE TriNetX

Real-world data (RWD), artificial intelligence (AI), and patient-centric trial design lead pharma priorities in 2025, but data compatibility, regulatory hurdles, and security concerns threaten to stall momentum.

CAMBRIDGE, Mass., July 10, 2025 /PRNewswire/ -- As biopharmaceutical companies double down on innovation and patient-centric research, a new industry survey from studioID and TriNetX reveals widespread integration of RWD and AI in drug development but also exposes critical challenges that could hinder industry-wide transformation.

"Real-world data is no longer a concept, it's a capability," said Steve Kundrot, Chief Operating Officer at TriNetX.

The survey, which polled 150 senior executives across pharma and biotech, found that:

  • 77% of organizations use RWD in at least some drug development tasks
  • Over 50% have already paired AI with RWD, unlocking faster, more actionable insights
  • 93% believe AI technologies can make RWD more accessible and impactful

"Real-world data is no longer a concept, it's a capability," said Steve Kundrot, Chief Operating Officer at TriNetX. "The leaders we surveyed see its value and are investing in execution. But to fully realize real-world data's promise, we must tackle integration challenges, enforce data standards, and build trust in AI applications."

Surging Use of RWD in Clinical Trials Faces Data Compatibility Roadblocks

Respondents reported using an average of 5.3 sources of RWD, including lab (77%), genomics (62%), registry (61%), and health equity data (61%). However, data compatibility concerns (29%) emerged as the top barrier to broader use.

To overcome this, Kundrot emphasized the need for data harmonization and semantic alignment: "It's important to find a trusted data partner that can integrate disparate sources across healthcare organizations and geographies while maintaining fidelity and privacy."

Momentum Builds for Inclusive, Patient-Centric Trials-But Regulatory and Access Hurdles Persist

The survey confirms a growing industry trend toward inclusive, patient-centric clinical trials:

  • 84% of executives report increased efforts toward inclusion
  • 99% plan to sustain or expand those efforts in coming years
  • 71% cite RWD as a top initiative supporting patient engagement

Still, progress is not without obstacles. Regulatory complexity (36%) and accessibility challenges (34%) are the most cited barriers to broader representation.

"Regulatory uncertainty can stall inclusive trial design, even when the intent is there," said Jeffrey Brown, PhD, Chief Scientific Officer at TriNetX. "Real-world data, especially social determinants of health, helps uncover patient realities and generate the kind of evidence regulators are looking for. It's the bridge between inclusion goals and regulatory confidence."

Biopharma Backs Real-World Evidence (RWE) for Regulatory Submissions; However, Effectiveness Hinges on Data Quality and Study Design

In a unanimous vote of confidence, 100% of respondents agreed that RWE can improve regulatory submissions, a milestone for biopharma's evolving evidence generation strategies. Yet, success requires strategic execution.

"You have to ensure real-world data is fit-for-purpose and applied to sensible use cases," noted Brown. "To succeed with regulators, biopharma must ensure data quality, proper study design, and ethical application, especially in rare disease research where new trials may not be feasible."

AI Integration with RWD Accelerates, While Data Security Concerns Threaten Trust and Scalability

While AI adoption escalates, 36% of respondents cite data security as a top concern when combining AI with RWD. Kundrot advises organizations to implement strict privacy controls and demand audit rights with AI partners. "AI's potential is enormous," he said, "but without trust and transparency in how data is processed and protected, adoption with falter."

Download the Full Survey Report
The complete survey findings, commentary from TriNetX experts, and strategic recommendations are now available in the full report: What Pharma Leaders Really Think About AI, RWD & Inclusion.

About TriNetX, LLC
TriNetX operates the world's broadest federated network of real-world data in partnership with healthcare providers and applies intelligence that accelerates innovation across the healthcare ecosystem. Through its self-service, HIPAA-, GDPR-, and LGPD-compliant platform of federated deidentified and anonymous electronic health record datasets and consulting partnerships, TriNetX empowers its global community to improve clinical trial protocol design, streamline trial operations, refine safety signals, and enrich real-world evidence generation. For more information, please visit TriNetX at www.trinetx.com or follow TriNetX on LinkedIn.

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