That's the purpose of the estimand framework—to define ahead of time, before you even start randomizing patients, everything that can happen, and then define the methods you will use to attenuate the ...

In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian ...

An in-depth thought leadership whitepaper explaining how sponsors can operationalize the FDA’s 2025 guidance on inclusive and representative clinical trial design. It outlines current industry ...

This article explores how adopting a “workflow” mindset anchored in measurable sponsor outcomes meets this challenge, ultimately yielding the lower costs, higher quality, and an architecture ready for ...

In addition to improving payment speed, accuracy, and transparency, modern payment technology is creating new opportunities to further improve the trial experience. For example, AI is being used to ...

Stay current in clinical research with Applied Clinical Trials, providing expert insights, regulatory updates, and practical strategies for successful clinical trial design and execution.

At the SCOPE Summit, Tekton Research shares how its physician-led clinical trial network is helping accelerate research in neuroscience and cardiometabolic disease. By pairing pra ...

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 ...

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 ...

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 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, examines the most common threats to trial data reliability, including opaque methodologies, synthetic controls, and the limits of ...