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.
|Podcasts|May 17, 2022
The Need For Pediatric Clinical Trials and Data
Author(s)Lisa Henderson, Andy Studna, Senior Editor
Dr. Salim Idriss, Executive co-director of the Duke Pediatric and Congenital Heart Center & director of pediatric electrophysiology at Duke University Medical Center discusses a collaboration with the Cardiac Safety Research Consortium (CSRC), the FDA, and Duke University Medical school.
Related to this article
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.
In today's ACT Brief, we examine how data drives honest enrollment assumptions, why RWE infrastructure lags ambition, and the disconnect between FDA rulemaking and enforcement on compounded therapies.
In today's ACT Brief, we examine what AI simulations surface in trial design, how RBQM delivers measurable financial returns, and three new FDA-approved treatments across hair loss, movement disorder, and bone disease.
In today's ACT Brief, we examine how AI is surfacing endpoint options beyond traditional design thinking, why sponsor oversight of outsourced work often fails on inspection despite being robust in practice, and a new combination drug for advanced kidney cancer.
Trending on Applied Clinical Trials Online
1
FDA Releases Transparency Roadmap Outlining Disclosure Priorities Across Drug Development and Regulatory Review
2
FDA Seeks Public Input on Early-Phase Clinical Trial Design for Ibogaine
3
Beyond the Molecule: Why Radiopharmaceutical Trials Require a New Operating Model
4
Operation TrialBlazer Leveraging New and Anticipated US Policy Changes in Early Development
5