Don Tracy, Associate Editor

Results from a retrospective study found that Amtagvi (lifileucel) achieved a 48.8% objective response rate in patients with advanced melanoma who had previously received immune checkpoint inhibitors.

Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.

Results from the Phase III EMBARK trial show that in combination with leuprolide, Xtandi (enzalutamide) demonstrated a statistically significant and clinically meaningful overall survival benefit in men with non-metastatic hormone-sensitive prostate cancer and high-risk biochemical recurrence.

The Phase I/IIa CLARICO trial of OpCT-001 marks the first clinical trial of an investigational induced pluripotent stem cell-derived therapy for primary photoreceptor diseases.

Results from the Phase III FORTITUDE-101 trial showed that bemarituzumab combined with chemotherapy demonstrated both statistical significance and clinical relevance in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who are FGFR2b-positive and HER2-negative.

Brian Ongioni, chief product officer, uMotif, discusses how AI and machine learning can enhance patient-reported outcomes by capturing meaningful feedback at scale and ensuring patient voices are reflected throughout the clinical trial lifecycle.

Brian Ongioni, chief product officer, uMotif, explains how early patient feedback plays a crucial role in shaping digital endpoints to ensure they are relevant, reliable, and acceptable to regulators and payers—ultimately improving clinical trial outcomes and data quality.

Brian Ongioni, chief product officer, uMotif, explains how early site feedback and patient involvement in software development help sponsors streamline clinical trial workflows and reduce burden on both sites and participants.

Peter Ronco, CEO, Emmes, shares his long-term vision for artificial intelligence in clinical research, from making automation routine to improving drug discovery, transforming regulatory oversight, reducing animal testing, and promoting ethical, equitable data use worldwide.

Peter Ronco, CEO, Emmes, explains how the company is investing in transparent goal setting, comprehensive education, and evolving talent strategies to embed AI-driven workflows across all teams—transforming the culture to embrace technology as a catalyst for innovation and efficiency in clinical development.

Brian Ongioni, chief product officer, uMotif, shares how early collaboration with patients and clinical sites helps shape intuitive, accessible digital health tools—and why co-design is key to building effective clinical research platforms.

Peter Ronco, CEO, Emmes, explains why AI in clinical development still needs human oversight despite widespread hype.

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.

Peter Ronco, CEO, Emmes, explains how public sector leaders are driving innovation in clinical development through automation, long-term data utilization, and experimental trial design—despite the private sector dominating the conversation around artificial intelligence.

Results from the Phase Ib/II CARTITUDE-1 trial demonstrated that a single infusion of Carvykti delivered durable, treatment-free remissions for at least five years in a third of patients with relapsed or refractory multiple myeloma.

In this video interview, Ron Lanton, partner, Lanton Law, highlights how tariffs on active pharmaceutical ingredients could affect resources for maintaining and accelerating R&D pipelines.

In this video interview, Ron Lanton, partner, Lanton Law, talks FDA layoffs and their impact on inspections and clinical trial timelines.

In this video interview, Ron Lanton, partner, Lanton Law, discusses how a potential increase in drug costs could affect the clinical research industry.

Full results from the Phase III ASCENT-04/KEYNOTE-D19 study demonstrated statistically significant and clinically meaningful survival benefits in patients with previously untreated, PD-L1-positive metastatic triple-negative breast cancer.

In the SmartfIRE study, the Thermocool Smarttouch SF catheter showed an 86.9% effectiveness rate among patients treated with high adherence to recommended ablation parameters.

Andrew Mackinnon, Executive GM, Medable, discusses how AI-driven innovations are streamlining clinical trials through enabling scalable operations.

Andrew Mackinnon, Executive GM, Medable, explains how the company’s recent approval in France could support the expansion of digital and decentralized clinical trials across Europe, particularly through enhanced e-consent practices.

Andrew Mackinnon, executive GM, Medable, explains how the company ensures high patient participation and data accuracy in decentralized trials.

Ron Lanton, Partner, Lanton Law, shares his insights on the legal and political consequences of the NIH funding freeze and potential options for continuing research.

Ron Lanton, Partner, Lanton Law, discusses the impact of diversity bans and political challenges on the clinical trials industry.

Ron Lanton, Partner, Lanton Law, discusses how stakeholders must navigate funding future clinical research amid NIH budget cuts.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Shakthi Kumar, chief strategy & business officer, Edetek, provides examples of how Agentic AI can accelerate clinical development.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Graham Clark, CEO, Phastar, discusses key objectives for attending SCOPE, the rise of real-world evidence, and partnerships critical to improving the success of clinical trial outcomes.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sebastien Coppe, CEO, One2Treat, talks challenges faced by startups in advancing clinical trial innovation.