In today's ACT Brief, we examine the FDA's multi-domain transparency priorities, why radiopharmaceutical trials need redesigned infrastructure, and how AI can make enrollment more predictable.
News|Podcasts|July 20, 2026
ACT Brief: Portfolio-Level Recruitment Strategy, Structural Change Through Systems Thinking, and Kidney Function Preservation in IgAN
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine how programmatic recruitment requires portfolio funding and behavioral readiness integration, why clinical R&D modernization stalls without systems-level thinking, and FDA's traditional approval of a kidney function-preserving therapy.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a new
FAQ , we addressed how the FDA's shift to single pivotal trials raises recruitment stakes for sponsors, requiring movement from study-by-study outreach to programmatic, relationship-based approaches. Success requires portfolio-level funding, cross-study governance, and integration of behavioral readiness screeners with clinical eligibility, treating patient engagement as long-term strategic capability rather than per-study operational task. - In a new contributed
article , Kelsey Jakee, senior director of portfolio strategy and innovation at TransCelerate BioPharma, examined why clinical R&D modernization stalls through incremental optimization of individual workflows. Meaningful systemic change requires leaders to visualize structural relationships, understand hidden incentives, and identify leverage points that benefit the whole system, moving beyond siloed solutions toward interoperable models that prioritize long-term efficiency over short-term convenience. - FDA converted Fabhalta's accelerated
approval to traditional approval based on Applause-IgAN Phase III data showing benefit in kidney function decline versus placebo over two years. The conversion from proteinuria reduction to kidney function preservation as the approval anchor strengthens the linkage to clinically meaningful outcomes such as dialysis and transplantation risk reduction.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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