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In this video interview, Ananth Kadambi, VP of real-world evidence and modeling solutions at Certara, outlines how FDA’s emphasis on overall survival in oncology trials requires stronger safety monitoring, subgroup planning, and patient tracking.

Paul Shawah, EVP, strategy, Veeva Systems and Richard Staub, president, R&D solutions, IQVIA, explain how their partnership is improving efficiency and data management in clinical trials by integrating best-in-class technology with expert services to benefit sponsors and accelerate drug development.

Donna Libretti Cooke, JD, an independent consultant working in the clinical operations space, outlines ways to build fair, just, and effective participant-centered compensation frameworks.

Real-world data from more than 58,000 older adults with type 2 diabetes and cardiovascular disease demonstrate that semaglutide lowers the risk of major adverse cardiovascular events, reinforcing its differentiated profile among GLP-1 receptor agonists.

In an era of constant policy change, timely real-world data is emerging as pharma’s most critical tool to track patient access, anticipate shifts in treatment utilization, and improve outcomes in real time.

Paul Shawah, EVP, strategy, Veeva Systems and Richard Staub, president, R&D solutions, IQVIA, explain how their partnership is accelerating global clinical trials by streamlining processes, improving data management, and enabling sponsors to bring new treatments to patients faster.

The full value of clinical data will only be unlocked by redesigning how it’s captured, connected, and applied to accelerate decisions, improve trials, and better serve patients.

In this episode of the ACT Brief, we spotlight an earlier interview with Ron Lanton, partner at Lanton Law, in which he discussed how rising drug costs, reduced FDA inspections, and potential tariffs on active pharmaceutical ingredients could increase costs and slow progress across the clinical research landscape.

An interim analysis of the TULIP-SC trial found that weekly subcutaneous delivery of Saphnelo significantly reduced disease activity in patients with moderate to severe SLE, offering a more convenient option with a safety profile consistent with IV administration.

Paul Shawah, EVP, strategy, Veeva Systems and Richard Staub, president, R&D solutions, IQVIA, discuss how their partnership leverages cutting-edge technologies and integrated services to improve data accuracy, streamline workflows, and drive greater efficiency in global clinical trials.

Full patient enrollment in REVEAL-1 (NCT06812325) and REVEAL-2 (NCT06625398) trials mark a key milestone for VRDN-003, Viridian’s promising new therapy for thyroid eye disease.

A quick look at FDA’s 2025 transparency moves, what CRLs are (and aren’t), how FAERS works and its limits, who can report, and where the agency is applying AI.

Paul Shawah, EVP, strategy, Veeva Systems and Richard Staub, president, R&D solutions, IQVIA, discuss how their global partnership is streamlining workflows, integrating data and AI, and driving better outcomes for patients.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how large sample size and stratification by immunosuppressant use ensured balance and consistent efficacy assessments in the NIMBLE study.

Preliminary Phase IV trial results show that Moderna’s 2025–2026 Spikevax formula boosted neutralizing antibodies more than eight-fold in high-risk adults and older populations against COVID-19.

Maximizing AI’s potential in medical writing and regulatory submissions requires data standardization, objective content practices, and a streamlined document ecosystem that accelerates timelines while ensuring compliance.

Clinical trial enrollment and retention challenges, coupled with limited site resources, highlight the need for stronger site support, collaboration, and patient-centered trial models.

The Phase II trial (NCT07145229) will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 compared with placebo and standard colchicine therapy in over 200 patients with acute gout flares.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, describes how double-blind double-dummy dosing, standardized assessments, and site training ensured protocol adherence and data integrity in the NIMBLE trial.

The IDeate-Lung01 trial showed a 48% confirmed response rate with Merck’s B7-H3 directed antibody-drug conjugate in previously treated extensive-stage small cell lung cancer, with durable benefit observed across second- and later-line patients, including those with brain metastases.

In this week’s Applied Clinical Trials Brief, we recap three top stories: Novo Nordisk’s stepwise approach to AI adoption, new perspectives on eClinical technology as a growth driver, and expert insights on how recent policy changes could impact research funding and future therapies.

Interim results from the ongoing Phase IV LOTUS trial showed that Daybue delivered sustained behavioral improvements and manageable gastrointestinal outcomes in Rett syndrome patients over one year.

Results from the Phase III STRIDE-13 trial (NCT06177912) showed that Merck’s Capvaxive was noninferior to PPSV23 in children and adolescents aged 2 to <18 years who are at increased risk of pneumococcal disease due to chronic medical conditions.

In this video interview, Umesh Chaudhari, executive medical director and global program head of the C5 programs at Regeneron, explains how NIMBLE showed cemdisiran achieved strong efficacy with partial complement inhibition and reduced disease worsening compared to combination therapy.

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.