In today's ACT Brief, we explore how continuous remote monitoring enables early clinical interventions, FDA guidance on validating new approach methodologies as alternatives to animal testing, and the importance of transparent data collection in decentralized trials.
In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, explains how continuous remote monitoring enables earlier detection of patient deterioration and allows care teams to intervene before conditions escalate to hospitalization.
New framework establishes scientific standards for alternative methodologies, signaling a regulatory shift toward human-centric data in preclinical drug development.
In today's ACT Brief, we explore how wearable data is informing real-world clinical decision-making, a statistical method that analyzes multiple patient outcomes simultaneously to improve trial design, and legal challenges to recent vaccine advisory committee changes.
In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how wearable devices are giving clinicians a unique window into patient health outside the clinic and why that real-world visibility is becoming essential to modern care.
In today's ACT Brief, we examine the technology infrastructure gap facing investigator-initiated trials, how transparency and community engagement drive vaccine adoption, and why workflow orchestration—not just digitization—delivers operational value in clinical research.
In this video interview, Marc Buyse, ScD, founder and CEO of IDDI, makes the case for generalized pairwise comparisons and the win ratio as transformative approaches to trial analysis that incorporate multiple outcomes simultaneously and better reflect what matters most to patients.
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.
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.
