ACT Brief: Decentralized Innovation Faces Reality, RWE Finds Its Lane, and Clinical Ops Reset for 2026

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

• In a new ACT column, Tufts CSDD’s Ken Getz says decentralized adoption of clinical research innovation is unavoidable but poorly optimized across the industry. He notes that while centralized investment creates early momentum, adoption ultimately stalls without functional-level ownership, incentives, and change management. Getz adds that a new Tufts CSDD working group aims to benchmark best practices for accelerating decentralized adoption without losing impact.
• In part three of her ACT interview, Inovalon’s Jen Lamppa says real-world evidence most effectively complements traditional trials on the observational end of the research spectrum. She points to post-market surveillance, label expansion, and long-term safety studies as areas where secondary real-world data can realistically replace prospective trials. Lamppa adds that rare disease and medical device development remain key use cases as FDA guidance continues to evolve.
• A new ACT FAQ article outlines how efficiency pressures, platformization, AI infrastructure, and non-traditional players are expected to converge in 2026. Industry leaders anticipate a shift away from fragmented tools toward living protocols, explainable AI, and integrated care models that embed research closer to patients. The article notes that while FDA policy activity is recovering slowly, sponsors are increasingly expected to execute—not experiment—as operational expectations reset.

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