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A biomarker test now decides who enters a precision medicine trial, yet results often go unused and assays are not ready when screening opens.

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.

Real-time RBQM requires proportionate analysis frequency matched to data arrival and issue criticality, not continuous reanalysis, because signal churn from over-frequent runs creates alert fatigue and operational noise that obscures meaningful deterioration.

In this video interview, Saamir Pasha and Carole Berini, PhD, of Ontada, explain how building trust into the data foundation—through source lineage, standardization, and reconciliation—is what makes reliable real-world evidence generation in oncology possible.

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.

Site training effectiveness depends on readiness at first-patient-in, requiring learning-science design principles around performance focus, cognitive load reduction, progressive sequencing, and spaced retrieval practice rather than training completion metrics or content volume.

In this Q&A, Claire Riches, VP of clinical solutions at Citeline, discusses how AI is transforming endpoint selection and protocol pressure-testing, what data inputs matter most for realistic enrollment planning, and why the tools are more accessible than most sponsors assume.

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.

Radiopharmaceutical therapy is exposing a broader challenge for clinical development: scientific innovation can advance only as fast as the infrastructure, data, and cross-functional decisions required to deliver it.

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.

Mixed FSP and FSO models are gaining ground as sponsors seek agility and resource flexibility, but the oversight infrastructure, audit trails, and accountability structures needed to run them well and survive regulatory inspection are consistently lagging behind the model itself.

A new request for information asks for comments on dose selection, safety monitoring, eligibility criteria, and oversight approaches to support the responsible development of ibogaine drug products.

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.