#USA #Cambridge #Artificial Intelligence #Biopharmaceutical #Real World Data

Introduction

A recent survey from studioID and TriNetX highlights the burgeoning use of Real World Data (RWD) and Artificial Intelligence (AI) within the biopharmaceutical industry. The shift towards innovation and patient-centered research is reshaping how drugs are developed, offering new opportunities but also presenting significant challenges.

Survey Insights

Conducted among 150 executives from the pharmaceutical and biotech sectors, the survey revealed that:

• - 77% of companies utilize RWD for drug development tasks.
• - Over half have integrated AI with RWD to derive faster and more actionable insights.
• - An overwhelming 93% believe that AI technologies can enhance the accessibility and effectiveness of RWD.

Steve Kundrot, COO of TriNetX, commented, "Real World Data is no longer just a concept; it's a capability. The executives we've surveyed see its value and are investing in its implementation. However, to fully harness the potential of RWD, we must overcome integration challenges, enforce data standards, and build trust in AI applications."

Challenges in Data Compatibility

While RWD is increasingly utilized in clinical trials, issues regarding data compatibility remain a major barrier. On average, respondents reported using 5.3 sources of RWD, including:

• - 77% from laboratory data
• - 62% from genomic data
• - 61% from registries and health equity data

However, concerns about data compatibility were cited by 29% of respondents as a significant obstacle to wider usage. Kundrot emphasized the necessity for data harmonization and semantic alignment, asserting the importance of finding reliable data partners capable of integrating diverse sources across healthcare organizations while ensuring data integrity and privacy.

The Shift Towards Inclusive Clinical Trials

The survey also indicated a growing industry trend towards inclusive, patient-centered clinical studies, with:

• - 84% of executives noting increased efforts for integration.
• - 99% planning to continue or expand these efforts in the coming years.
• - 71% highlighting RWD as a crucial initiative to boost patient engagement.

Nonetheless, the path forward remains fraught with hurdles, including regulatory complexities (36%) and accessibility issues (34%), which are frequently cited as barriers to broader representation in studies. Jeffrey Brown, PhD, scientific leader at TriNetX, remarked, "Regulatory uncertainties can delay the development of comprehensive studies, even when intentions are good. RWD, particularly concerning social determinants of health, can uncover patient realities and provide the type of evidence regulators seek. It serves as a bridge between integration goals and regulatory trust."

RWE's Role in Regulatory Submissions

An overwhelming 100% of respondents concurred that Real World Evidence (RWE) could enhance the submission of regulatory applications—an encouraging sign for the evolving strategies within biopharma to generate evidence. However, achieving success demands strategic implementation.

Dr. Brown stated, "It's essential that Real World Data be relevant and employed for meaningful applications. To succeed with regulators, the biopharma sector must prioritize data quality, appropriate study designs, and ethical applications—especially when investigating rare diseases, where new studies may be unfeasible."

Concerns Regarding Data Security

As AI adoption accelerates, data security emerges as a primary concern for 36% of respondents when combining AI with RWD. Kundrot advises companies to establish stringent data privacy controls and demand audit rights from AI partners. He noted, "The potential of AI is immense, but without trust and transparency in data processing and protection, acceptance will stall."

Conclusion

The full survey report, replete with additional commentary from TriNetX experts and strategic recommendations, is now available for download. It provides valuable insights into what pharmaceutical leaders truly think about AI, RWD, and inclusion in clinical research.

About TriNetX

TriNetX operates the world’s largest federated network of real-world data in partnership with healthcare providers, applying intelligence to accelerate innovations across the healthcare spectrum. Its self-service platform is HIPAA, GDPR, and LGPD compliant and allows the global community to enhance study protocol design, optimize operations, refine safety signals, and enrich evidence generation from practice. For more information, visit TriNetX or follow them on LinkedIn.