ACT Brief: Trial Execution Cost Burden and Protocol Variability, Real-World Oncology Data Curation Complexity, and Real-Time Analytics Datapoint Scale

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

• In a contributed article, Richard Graham, chairman and co-founder of TruTechnologies, examined how poor execution at the point of care drives most trial delays and what poor execution costs. Tufts estimates delayed market entry at approximately 500,000 dollars per day in unrealized sales, with Phase III trials costing nearly 56,000 dollars per day in direct conduct costs; multiplied across sites and phases, capture and documentation inconsistencies become material trial risks that AI discovery tools cannot fix.
• In a new contributed article, C.K. Wang, chief medical officer at Verana Health, described why real-world oncology data requires a hybrid curation approach pairing clinical expertise with technology. Complex oncology concepts like lines of therapy and treatment exposure remain implicit rather than explicit in electronic health records, requiring both advanced algorithms and clinical expert validation to ensure data plausibility and research readiness.
• In an article from Pharmaceutical Executive, Christian Schmidt examined how escalating datapoint volumes are overwhelming traditional data management. Phase III trials now generate an average of 5.9 million datapoints per protocol, up 11 percent annually since 2020, while most sponsors still manage data manually with periodic reviews weeks after collection, delaying detection of protocol deviations and adverse events.

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