Andy Studna, Senior Editor

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.

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.

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.

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.

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 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.

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.

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.

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.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, explains why unified, real-time trial platforms are essential for reducing physician burden and improving patient access to studies.

Aligning artificial intelligence with patient needs, trial workflows, and employee experience enables adoption, builds trust, and ensures AI delivers measurable impact across clinical operations.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed articles of the week—spotlighting Veeva and Merck’s push for platform-driven trial efficiency, Sunny Kumar’s perspective on barriers slowing decentralized adoption, and the evolving role of blood glucose meters and continuous glucose monitors in clinical research.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, discusses how AI-powered pre-screening integrated into referral workflows can streamline eligibility checks and speed patient access to treatments.

In this Q&A from the 2025 Veeva R&D and Quality Summit, Ibrahim Kamstrup-Akkaoui, vice president of data systems innovation at Novo Nordisk, discusses simplifying system use through the company’s DataNow program and taking a measured, stepwise approach to applying AI and automation across the clinical development lifecycle.

In this video interview, Adrianne Rivard, senior community development manager at myTomorrows, explains how AI can reduce the time physicians spend pre-screening patients for clinical trial eligibility.

In the clinical opening keynote of Veeva’s R&D and Quality Summit, Jim Reilly of Veeva and Jennifer Sheller of Merck outlined how connected clinical platforms can cut costs, reduce inefficiencies, and improve site and patient experiences, with Merck’s “Zero Gravity” program demonstrating early operational gains.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how startups often underestimate the need for scalable platforms that fit into pharma workflows, limiting adoption of otherwise promising point solutions.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how FDA guidance and investor expectations are shaping resilient trial designs that use adaptive methods, virtual controls, and decentralization to lower costs and accelerate patient access.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how organizational complexity, regulatory caution, and cultural risk aversion slow innovation in clinical trials, while tools like generative AI may help reduce operational barriers.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, discusses how clinical operations leaders can close technology gaps in decentralized trials by provisioning devices and designing simple, intuitive tools to ensure equitable patient access.

The Phase III NIMBLE trial met its primary and key secondary endpoints, with cemdisiran monotherapy showing robust efficacy in generalized myasthenia gravis and the cemdi-poze combination achieving near-complete complement inhibition. Regeneron plans a 2026 US regulatory submission.

In this video interview, Sunny Kumar, MD, partner at Informed Ventures, explains how high upfront costs and limited proof of cost savings are slowing large-scale adoption of decentralized clinical trial models.

Craig Lipset, co-chair, Decentralized Trials & Research Alliance (DTRA), and Kyle McAllister, co-founder, CEO, Trially, discuss how research sites are navigating political funding pressures, adapting to NIH budget constraints, and leveraging new cost-containment strategies to sustain clinical research.

The FDA will now publish adverse event data from FAERS on a daily basis, marking a major step toward greater transparency in drug development.

In this episode of the Applied Clinical Trials Brief, we recap our three most-viewed stories of the week—covering the Supreme Court’s decision to uphold NIH funding cuts tied to DEI, Phase II data showing oral VK2735 achieved over 12% weight loss, and Phase III results where Padcev plus Keytruda improved survival in muscle-invasive bladder cancer.