ACT Brief: Real-World Data Across Therapeutic Areas, AI-Driven Case Intake, and COVID-19 Vaccine Trial Enrollment Challenges

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In research from Tufts CSDD and Verana Health, real-world data adoption varies significantly by therapeutic area, with oncology demonstrating high-confidence applications for inclusion criteria, sample size, and accelerated approvals, while urology remains largely exploratory. Organizations cite challenges around data quality, cross-functional alignment, and ROI quantification, but anticipate broader integration of RWD into trial design and site selection within the next one to two years.
• In part one of a new video interview series, Krishna Cheriath, vice president and head of clinical research digital data and AI at Thermo Fisher Scientific, discussed how AI is being applied to case intake today. Successful adoption depends less on technology than on reimagining workflows and investing in workforce upskilling to leverage AI effectively within existing operational contexts.
• Pfizer and BioNTech halted a 25,000 to 30,000 participant COVID-19 vaccine trial targeting healthy adults aged 50 to 64 after enrollment shortfalls made it impossible to generate FDA-required post-marketing data. Stringent eligibility criteria excluding chronic conditions caused over 80% of willing participants to fail pre-screening, reflecting broader challenges in recruiting healthy adults for vaccine trials amid declining COVID-19 booster uptake.

That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.