News

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.

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.

Results from a Phase III trial (NCT07069309) demonstrated that the LP.8.1-adapted Comirnaty vaccine generated a robust fourfold increase in neutralizing antibodies of COVID-19.

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.

Phase IIa trial (NCT06413537) results show SPG601 improves neurophysiological and cognitive measures in patients with Fragile X syndrome.

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 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 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.

Results from the Phase II EPCORE NHL-6 trial (NCT05451810) showed that Epkinly demonstrated an overall response rate of 64.3% in patients with relapsed or refractory diffuse large B-cell lymphoma.

Designation supports the potential of olomorasib plus Keytruda to address unmet needs in the first-line treatment of patients with KRAS G12C-mutant non-small lung cancer with high PD-L1 expression.

Results from the Phase IV V-DIFFERENCE trial (NCT05192941) found that 85% of patients on Leqvio reached guideline-recommended LDL-C targets versus 31% on placebo at 90 days.

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.

Results from the Phase III CORALreef Lipids trial (CT05952856) showed that patients treated with enlicitide decanoate for hypercholesterolemia demonstrated statistically significant and clinically meaningful reductions in LDL cholesterol.

Results from the Phase III BaxHTN trial (NCT06034743) showed baxdrostat achieved statistically significant and clinically meaningful reductions in systolic blood pressure in patients with hard-to-control hypertension.

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.

The ZENITH outcomes trial will enroll 11,000 patients worldwide to evaluate twice-yearly zilebesiran, aiming to improve long-term blood pressure control and reduce cardiovascular risk in uncontrolled hypertension.

The Phase III VICTOR trial (NCT05093933) evaluated Verquvo in patients with stable, well-treated chronic heart failure and reduced ejection fraction without a recent worsening heart failure event.

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.