In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, reflects on the gap between sponsor expectations and statistical reality, drawing on lessons from the COVID era to argue for more ...
ACT Brief: Trial Data Transparency, Protocol Design Drives Enrollment, FDA Shifts Approval Standards
In today's ACT Brief, we examine why transparency in complex trial designs is essential for data confidence, how protocol structure—not operational effort—determines recruitment success, and the FDA's ...
In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian ...
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, examines the most common threats to trial data reliability, including opaque methodologies, synthetic controls, and the limits of ...
In today's ACT Brief, we explore how Bayesian methods are reshaping FDA interactions and trial design, quality tolerance limits are becoming operational guardrails in risk-based quality management, ...
Closing the gender gap in data science and tech requires tackling barriers at every stage, from early education through career advancement, while actively challenging the unconscious biases that ...
In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is ...
The Patient Advocate Foundation and the PAN Foundation have announced a strategic merger to create the nation’s most ...
In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is ...
As rare disease trials face persistent feasibility challenges, Bayesian designs are gaining momentum by enabling more ...
For many years the clinical trial industry has treated older adults as a recruitment challenge, particularly in digital environments. Yet behavioral data from modern recruitment c ...
Public-private collaboration and structured evidence consolidation are emerging as critical enablers of regulatory-ready digital endpoints, helping standardize terminology, reduce duplication, and ...
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