Trialbee CEO Matt Walz explores the current impact of AI in delivering practical gains in clinical development and reflects on its future potential, where enrollment predictability may be the biggest prize of all.
News|Podcasts|September 2, 2026
ACT Brief: RBQM Financial Value Quantification, Trial Budget Cost Visibility Gap, and GSK mRNA Flu Vaccine Phase III
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine how eNPV modeling and real-world data finally put numbers on RBQM value, why static budgeting masks true site costs, and GSK advancing an mRNA flu vaccine candidate to late-stage testing.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In
part one of a new video interview , Sylviane de Viron of CluePoints, and Abigail Dirks of Tufts CSDD explained how combining real-world deployment data with eNPV modeling finally made it possible to put a number on the financial value of RBQM. Oncology was chosen as a conservative starting point because it has the largest data set, giving the model the highest confidence that results would be defensible across other therapeutic areas. - In a
new contributed article , Tina Mincher and Shelley Douros examined how static budgeting models and one-size-fits-all fair market value approaches create visibility gaps around inflation and true site costs. Regional frameworks, standardized costing toolkits, and accountability metrics can rebuild trust and replace defensive negotiations with transparency. GSK is advancing its mRNA seasonal flu vaccine to Phase III testing , starting in September, based on positive Phase II data showing higher immune response against all flu strains compared with licensed vaccines. The vaccine is designed to target both surface proteins that cause the virus to bind and spread, a dual-target approach growing evidence suggests could improve protection and reduce transmission.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
Related to this article
In today's ACT Brief, we examine proportionate analysis frequency in RBQM, how to build trust into real-world evidence foundations for cancer trials, and how rare disease developers monetize regulatory success.
In today's ACT Brief, we examine how AI surfaces design flaws before enrollment, why site training readiness depends on learning science, and the priorities defining next-generation weight-loss therapies.
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.
In today's ACT Brief, we examine FDA input sought on early-phase ibogaine protocols, why mixed outsourcing models spread faster than oversight infrastructure, and a major partnership for a rare kidney disease treatment.
In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
In today's ACT Brief, we examine how AI enables sponsors to pressure-test protocols before enrollment, HHS's multi-initiative effort to accelerate trial design and execution, and FDA approval expanding heart disease therapy to adolescents.
In today's ACT Brief, we examine AI's role as trial design advisor with human leadership, how to govern autonomous agents in regulated operations, and real-world outcomes from switching to oral weight-loss therapy.
Trending on Applied Clinical Trials Online
1
AI and Patient Recruitment: Can Predictive Promise Drive True Transformation?
2
Beyond Outreach: Structural Drivers of Representation in Clinical Trials
3
Flexible Clinical Operations and Site Management Across a Diversified Biotech Portfolio: An Application of Quality by Design and Risk-Based Oversight
4
Start Study Budgets Sooner With AI-Enabled Protocol Translation
5