News

The next phase of digital transformation in clinical research will not be defined by the number of platforms deployed, but by how well those platforms work together in service of participants, sites, and science.

In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, explains how early-stage planning, the estimand framework, and anticipating trial conduct problems can protect data integrity and make results more convincing and actionable.

Participant payment processes in clinical trials are evolving as sponsors and sites adopt automated technologies to improve payment speed, accuracy, transparency, and payment flexibility while reducing administrative burden on site staff and supporting participant engagement and retention.

Older adults generate disproportionately high engagement in digital trial recruitment, suggesting they represent an overlooked opportunity when recruitment systems are designed around their actual behavior rather than outdated assumptions about digital capability.

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 pragmatic, cost-efficient trial execution and greater patient access to clinical research.

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 streamlined biosimilar development pathway aimed at reducing drug costs.

Most protocol deviations start as human problems, not operational ones, but risk-based monitoring typically relies on lagging indicators that arrive too late to prevent these problems instead of measuring readiness during training, when intervention still matters.

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 AI-driven analysis, while making the case for explainable, transparent trial design.

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 shift toward single-trial approvals with enhanced post-market surveillance.

In this first part of a 2-part perspective, clinical trial recruitment failures are reframed as design outcomes, making the case for embedding enrollment feasibility into protocol governance from the start.

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, and leadership transitions at the FDA's Center for Biologics Evaluation and Research signal evolving regulatory priorities.

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 sizes are small.

In this video interview, David Morton, PhD, director of biostatistics at Certara, reflects on the growing role of Bayesian approaches in modern drug development, emphasizing their potential to improve decision-making, efficiency, and overall trial success.

In today's ACT Brief, we explore the operational capabilities clinical teams need to implement Bayesian trial designs, why gender diversity strengthens data science across drug development, and the FDA's rejection of external controls for a Huntington's gene therapy candidate.

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 continue to hold women back.

In this video interview, David Morton, PhD, director of biostatistics at Certara, explores the practical challenges of implementing Bayesian designs, including the need for simulation, cross-functional alignment, and clear communication with regulators.

In today's ACT Brief, we explore how Bayesian approaches are powering studies in rare disease and pediatrics, a major public-private initiative is standardizing digital endpoints for regulatory acceptance, and the FDA intensifies enforcement against misleading GLP-1 marketing.

Public-private collaboration and structured evidence consolidation are emerging as critical enablers of regulatory-ready digital end points, helping standardize terminology, reduce duplication, and accelerate the integration of digital health technologies into clinical research and decision-making.

In this video interview, David Morton, PhD, director of biostatistics at Certara, outlines how increasing FDA support is helping drive adoption of Bayesian methods, particularly in rare disease and small population studies where efficiency is critical.

In today’s ACT Brief, we highlight how Bayesian methods are reshaping adaptive trial design, a major eSource partnership is improving data flow and accuracy, and FDA approval standards continue to evolve.

New collaboration connects site-level eSource with enterprise platforms, reducing manual workflows and accelerating real-time data flow across global clinical trials.

In this video interview, David Morton, PhD, director of biostatistics at Certara, explains how regulatory momentum is encouraging sponsors to move beyond traditional methods, leveraging Bayesian frameworks to improve efficiency, particularly in rare disease and small population studies.

In today’s ACT Brief, we highlight how Bayesian methods are gaining operational traction, a major patient advocacy merger is streamlining clinical trial access, and machine learning is reshaping trial design through multi-modal data integration.

In this video interview, David Morton, PhD, director of biostatistics at Certara, discusses how growing FDA support is accelerating the adoption of Bayesian approaches, enabling more flexible, data-driven trial designs through external data borrowing, adaptive decision-making, and simulation-based planning.

Nonprofit merger aims to streamline financial assistance, case management, and trial participation resources for patients navigating complex care pathways.

In today’s ACT Brief, we examine how the Verana Health-COTA merger is evolving real-world data use, the FDA’s new framework for individualized ultra-rare disease therapies, and what a decade of cross-industry collaboration reveals about the future of clinical development.

Draft guidance outlines a “plausible mechanism” pathway to support approval of highly targeted therapies when traditional trials are not feasible.

In this episode of the Applied Clinical Trials Podcast, C.K. Wang, MD, chief medical officer at COTA; and Sujay Jadhav, CEO of Verana Health, discuss how their organizations’ merger is advancing the use of real-world data to inform trial design, patient recruitment, and regulatory decision-making.