Words by Isabel O’Brien
A new survey has found that the use of artificial intelligence and real-world data (RWD) is on the rise across the biopharma industry, but significant hurdles remain for broader adoption.
The research, conducted by BioPharma Dive for health data firm TriNetX, polled 150 pharma and biotech leaders and found that three-quarters of organisations are already using RWD in drug development, with more than half integrating it with AI tools to accelerate insights.
Organisations are relying on RWD for a broad range of activities, including tracking medication use, supporting regulatory submissions and identifying participants for clinical trials. On average, companies are drawing data from more than five sources, including lab test results (77%), genomic information (62%), patient registries (61%) and health equity data (61%).
However, data compatibility emerged as the top barrier to progress, cited by nearly a third respondents. Data often arrives in inconsistent formats, with different definitions and quality standards. This can slow or disrupt the translation of raw data into insights by AI, leading lost value and credibility.
Steven Kundrot, Chief Operating Officer, TriNetX, stressed the need for greater harmonisation across data sources. “Real-world data is no longer a concept, it’s a capability. The leaders we surveyed see its value and are investing in execution. But to fully realise real-world data’s promise, we must tackle integration challenges, enforce data standards and build trust in AI applications.”
Complicating matters, the pressure to make clinical trials more inclusive is growing. The vast majority of leaders (84%) have increased their efforts to diversify trial participation, and almost all plan to expand these initiatives. But inclusion isn’t just a matter of intent: logistical and regulatory hurdles still stand in the way.
“Regulatory uncertainty can stall inclusive trial design, even when the intent is there,” said Jeffrey Brown, PhD, Chief Scientific Officer, 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.”
On the regulatory front, every respondent agreed that high-quality real-world evidence can strengthen drug approvals. But the survey warns that the benefits will only be realised if the underlying data is accurate, harmonised and incorporated into scientifically sound study designs.
