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Phase IV Trial Shows Daybue Demonstrates Real-World Behavioral Improvements in Rett SyndromeLatest News

Merck Reports Strong Phase II Results for Ifinatamab Deruxtecan in Extensive-Stage Small Cell Lung Cancer

ACT Brief Weekly Recap: How AI, eClinical Innovation, and Policy Shifts Are Reshaping Clinical Research

Phase IV Trial Shows Daybue Demonstrates Real-World Behavioral Improvements in Rett Syndrome

Capvaxive Demonstrates Robust Immune Responses in Children, Adolescents at Increased Risk of Pneumococcal Disease

NIMBLE Trial Reveals New Insights on Complement Inhibition in gMG

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Caroline Potts, general manager of sites and patient services at Medical Research Network (MRN), discusses how rigid budgeting and limited sponsor-site dialog often block innovative patient-centric solutions.

Michael Miller, chief operating officer at Quanterix, discusses how the use of biomarkers is expanding beyond exploratory endpoints to inform efficacy and patient selection, driving improved outcomes and greater efficiency in clinical research.

Luke Wilson, senior director, biotech, pharma services at Thermo Fisher Scientific, explains how clinical operations teams can use remote monitoring and connected technologies to reduce site burden, respond faster to emerging data, and improve both patient safety and trial outcomes.

Meri Beckwith, Co-CEO of Lindus Health, discusses a recent Complete Response Letter issued to Replimune, explaining how shifts in FDA reviewers can affect single-arm trial acceptance, especially in oncology settings where control groups may be deemed unethical.
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In this Q&A, Randa Wahid of Indero, and Lyn Mursalo, a freelance clinical research professional, share how sponsors and CROs can build collaborative partnerships, navigate global trial complexities, and apply practical strategies to deliver studies on time and with quality.

The FDA-approved therapy is now included in National Comprehensive Cancer Network clinical guidelines as a treatment option for both pediatric and adult patients with aggressive H3 K27M-mutant diffuse gliomas, offering a new standard of care for recurrent disease.

Results from the two-year AVONELLE-X extension study (NCT04777201) and the Phase IIIb/IV SALWEEN trial showed that Roche’s Vabysmo demonstrated durable vision improvements, extended dosing potential, and reliable safety treating wet age-related macular degeneration and polypoidal choroidal vasculopathy.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, outlines how the Phase III NIMBLE trial showed cemdisiran improved daily living and clinical assessments in patients with generalized myasthenia gravis.

The designation supports expedited development of SAR402663, Sanofi’s one-time gene therapy designed to reduce treatment burden and slow vision loss in patients with wet age-related macular degeneration.

In this episode of the Applied Clinical Trials Brief, Shipra Patel, global therapeutic area section head for endocrinology and global head of pediatrics at Parexel, shares insights on what makes a standout research partner, how cross-functional teams support GLP-1 studies, the role of real-world evidence, and why patient retention will be critical to shaping the future of obesity drug development.

The pivotal trial showed Eli Lilly’s non-covalent BTK inhibitor pirtobrutinib significantly improved progression-free survival over bendamustine plus rituximab in untreated CLL/SLL patients, with overall survival trending in favor of Jaypirca.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, explains why compliance with privacy standards and physician training are critical for safe and effective use of GenAI in clinical trial discovery.

Kate Gallin Heffernan, life sciences attorney at Epstein Becker Green, and Jim Kremidas, executive director, Association for MultiSite Research Corporations (AMRC), discuss how proposed policy changes could limit federal research funding, create uncertainty for clinical trial organizations, and slow the development of future therapies.

Results from a Phase II trial (NCT06449209) showed that BioNTech’s and Bristol Myers Squibb’s pumitamig in combination with standard chemotherapy demonstrated encouraging anti-tumor activity in patients with extensive-stage small cell lung cancer.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, highlights how combining AI platforms with patient navigators can make trial-finding tools more equitable and accessible across diverse healthcare settings.

New guidance and technology advances are reshaping eClinical systems, positioning them as tools to accelerate enrollment, improve data quality, and reduce site and patient burden.

Five-year results from the Phase III EMPOWER-Lung 3 trial show Libtayo combined with chemotherapy achieved a 19.4% overall survival rate versus 8.8% with chemotherapy alone, with notable benefit in squamous NSCLC patients reaching a median overall survival of 22.3 months.

Results from the Phase III ASCEND trial (NCT05882877) showed rocatinlimab maintained long-term efficacy with a favorable safety profile, offering potential for extended dosing intervals in adults with moderate to severe atopic dermatitis.

Results from the Phase III FLAUR2 trial (NCT04035486) showed that Tagrisso combined with pemetrexed and platinum-based chemotherapy achieved a median overall survival of 47.5 months in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer.