Don Tracy, Associate Editor

A new myTomorrows survey of physicians in the United States highlights the need for smarter, AI-driven tools to overcome inefficiencies in clinical trial access and improve patient care timelines.

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not an adequate, well-controlled study and that its heterogeneous patient population limited interpretability, preventing approval in its current form.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, discusses the importance of long-term patient retention, data accuracy, and AI-driven compliance tools in shaping the future of global obesity clinical trials.

Digital strategies such as video ads and pixel tracking helped researchers recruit faster, reach more diverse participants, and cut costs in a large-scale depression study.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world evidence is helping refine patient targeting and improve safety monitoring in obesity and endocrinology clinical trials.

The Phase III INDEPENDENCE trial (NCT04717414) failed to meet its primary endpoint of achieving transfusion independence in patients with myelofibrosis-associated anemia treated with Reblozyl (luspatercept-aamt).

Despite the setback with the Oncologic Drugs Advisory Committee vote, GSK emphasizes the unmet need in multiple myeloma and highlights global momentum behind Blenrep combination approvals.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how real-world data is helping researchers navigate gastrointestinal side effects, dose flexibility, and long-term tolerability in off-label GLP-1 use.

Results from the Phase III PURPOSE 1 (NCT04994509) and PURPOSE 2 (NCT04925752) trials highlight Yeztugo’s (lenacapavir) safety and efficacy in pregnant women, young adults, and others historically excluded from HIV prevention studies.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how therapeutic alignment and cross-functional collaboration enable the company to support GLP-1 trials across multiple disease areas.

Results from a Phase Ib trial (NCT03666000) show that azer-cel demonstrated a 75% overall response rate and a 55% complete response in patients with relapsed/refractory diffuse large b-cell lymphoma.

Shipra Patel, global therapeutic area section head, endocrinology, global head, pediatrics, Parexel, explains how a focused GLP-1 task force and deep market insights are helping sponsors stand out in an increasingly competitive obesity drug landscape

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.