In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|July 10, 2026
ACT Brief: Single Pivotal Trial Stakes, Configurable FSP Strategy, and G-CSF Biosimilar Portfolio Expansion
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine how FDA's single pivotal trial shift raises recruitment and retention stakes, why FSP should be viewed as a configurable continuum rather than binary choice, and a new pegfilgrastim biosimilar completing a major G-CSF portfolio.
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
interview , Gaynor Anders, chief delivery officer at Trialbee, explained how the FDA's shift toward single pivotal trials is raising the stakes on recruitment quality, feasibility precision, diversity, and retention. Sponsors now operate with reduced margin for error, making site selection, enrollment strategy, and participant engagement more critical to overall program success, fundamentally changing how they approach trial planning and execution. - In a new contributed
article , Nicole Duffey examined how FSP should be viewed as a configurable continuum rather than a binary outsourcing decision, challenging persistent misconceptions that FSP requires mature infrastructure or precludes hybrid approaches. Strategic deployment requires honest assessment of functional complexity, internal capacity maturity, and strategic priority, enabling sponsors to tailor engagement models to their specific needs without wholesale operational restructuring. - FDA
approved Accord BioPharma's Ennumo for febrile neutropenia prophylaxis in patients receiving myelosuppressive chemotherapy, including pediatric populations. The approval completes Accord's three-product G-CSF biosimilar portfolio and positions the company toward its goal of launching 20 biosimilars by 2030, expanding access to supportive care therapies across oncology practices.
That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.
Related to this article
In Episode 3 of The Human Side of Clinical Trials, hosts Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., and Kelly Ritch, chief operating officer of ArcheMedX, Inc., speak with Jason Riis, PhD, CEO and chief behavioral scientist at Behavioralize, about why a well-written protocol doesn’t always translate into consistent execution, and how designing for the way people actually think and learn can reduce site burden and the need for costly unlearning.
In today’s ACT Brief, we examine what it will take to scale EHR-to-EDC connections for real-time trials, how the FDA is reimagining rare disease drug development, and why oncology real-world evidence still faces persistent data barriers.
In today's ACT Brief, we examine how representation gaps in trials are shaped by structural design decisions, how new partnerships automate data transfer from site systems to sponsor platforms, and how Roche is licensing a novel obesity target from a biotech pioneer.
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.
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.
Trending on Applied Clinical Trials Online
1
Real-Time Clinical Trials Depend on a Scalable EHR-to-EDC Connection
2
FDA Launches Rare Disease Framework Initiative to Reimagine Drug Development for Small Patient Populations
3
The Human Side of Clinical Trials: Why Fuzzy Mental Models Undermine Clinical Trial Execution
4
What It Actually Means to Embed AI Across the Clinical Operating Model
5