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.
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 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 are now essential.
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.
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.
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.
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.
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.
In today’s ACT Brief, we explore how Bayesian trial designs are gaining traction in rare disease research, what priorities clinical operations leaders should focus on in 2026, and how rare disease science is shaping broader drug development strategies.
Jonathan Andrus, co-CEO of CRIO, discusses how governance across the data lifecycle, site-focused technology adoption, and scalable AI-enabled workflows will define operational readiness in 2026.
In today’s ACT Brief, we explore how sites are taking the lead on AI adoption to strengthen feasibility and enrollment, why earlier cross-functional alignment is critical in data-driven trials, and how Phase I strategy is shifting toward quantitative evidence generation.
Jonathan Andrus, co-CEO of CRIO, highlights the need for earlier cross-functional collaboration and greater site involvement to ensure data quality, workflow alignment, and operational success.
In today’s ACT Brief, we examine how fragmented data collection continues to challenge trial quality, how hybrid outsourcing and AI are reshaping execution strategies, and why calls are growing for a risk-based FDA pathway for early-stage studies.
As sponsors navigate rising complexity, AI adoption, and global scale, outsourcing strategies are shifting toward hybrid models, deeper CRO collaboration, and function-level flexibility to support execution in 2026.
Jonathan Andrus, co-CEO of CRIO, outlines how disconnected systems and inconsistent data collection across sites create risk, while centralized eSource approaches present a major opportunity.
In today’s ACT Brief, we examine how protocol-driven eSource is reshaping data capture at sites, how digital protocols and data sharing are redefining trial execution, and how a Duchenne study termination highlights growing operational risks in rare disease development.
Jonathan Andrus, co-CEO of CRIO, explains how protocol-driven eSource templates and standardized data capture are improving consistency, oversight, and efficiency across clinical trial sites.
In today’s ACT Brief, we examine how site-level data capture is becoming central to trial execution, how Merck and Mayo Clinic are scaling AI-driven discovery, and how Gilead’s latest acquisition strengthens its position in cell therapy for multiple myeloma.
Jonathan Andrus, co-CEO of CRIO, discusses how increased reliance on site-based technologies and eSource is strengthening data quality, compliance, and trust at the point of patient encounter.
