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 ...
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 ...
In today's ACT Brief, we explore the transparency demands of complex trial designs and synthetic controls, how measuring site readiness during training predicts protocol execution, and the FDA's ...
Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging ...
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 ...
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 ...
For more than a decade, patient recruitment and retention have been persistent hurdles in clinical research and are consistently cited as the biggest operational challenges with r ...
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, ...
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, discusses how increasing trial complexity is making data interpretation less straightforward and why transparency and reproducibility ...
Quality tolerance limits (QTLs) are trial-level thresholds on critical-to-quality (CtQ) factors—key measures where sustained deviation could affect safety or primary conclusions. They should be a ...
Quality tolerance limits work best as a small set of focused guardrails that prompt rapid investigation and documented action, not as documentation exercises, with early breaches expected when sample ...
In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian ...
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