Andy Studna, Senior Editor

Deal adds endpoint data collection and management platform to Thermo Fisher's clinical research portfolio, with Clario's technology having supported the majority of FDA and EMA novel drug approvals over the past decade.

In this Q&A, Mohammed Saeed, MD, PhD, chief medical officer at Solera Health, explores how wearable devices and continuous remote monitoring are reshaping clinical oversight, from early intervention to AI-driven pattern detection.

In today's ACT Brief, we explore how AI can parse wearable data streams to identify subtle clinical patterns, FDA's four major policy shifts modernizing drug development and approval standards, and ongoing questions about regulatory consistency in rare disease pathways.

In the first months of 2026, the FDA has moved on multiple fronts to modernize how drugs are developed, evaluated, and approved, signaling a broader regulatory shift toward flexibility, mechanism-based evidence, and human-centric science.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, explores how AI models capable of analyzing continuous wearable data streams alongside broader patient information could detect subtle warning signs of deterioration that no clinician could identify alone.

In today's ACT Brief, we explore how FDA clearance and reimbursement models support wearable adoption in clinical care, the importance of end-to-end data validation before patient enrollment, and FDA approval of a higher-dose semaglutide formulation for weight loss.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, discusses how regulatory trust-building and reimbursement reform are essential to making wearable devices a sustainable and widely adopted part of clinical care delivery.

In today's ACT Brief, we explore the data overload and alert fatigue challenges in integrating wearable data into clinical workflows, how cognitive and behavioral science can transform site readiness and training, and FDA's evolving guidance on rare disease trial design and evidence standards.

In this video interview, Mohammed Saeed, MD, PhD, chief medical officer of Solera Health, examines the operational challenges of incorporating wearable data into clinical workflows, including information overload and false alarm fatigue, and what those obstacles mean for patient safety.

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.