July 8th 2025
Outdated regulations and inflexible sponsor processes are hampering clinical trial recruitment, but empowering sites with modern, compliant marketing tools could turn the tide.
Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success
July 7th 2025How the application of artificial intelligence, broader use of real-world evidence, decentralized clinical trials, master protocols, and risk-based quality monitoring, together with strong ethical oversight and increased collaboration, are contributing to better healthcare delivery and strengthening the role of clinical research in driving global health progress.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
How AI Can Ease Recruitment Burdens in Resource-Strained Trials
July 2nd 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, explains how AI is stepping in to fill staffing gaps in clinical research—streamlining patient identification, real-time feasibility assessments, and automated prescreening to help sites stay operational and efficient despite budget cuts.
Once-weekly cagrilintide–semaglutide combination therapy produced unprecedented weight reductions in adults with overweight or obesity, with 60% achieving ≥20% loss and strong cardiometabolic benefits, according to Phase IIIa trial results published in The New England Journal of Medicine.
How Sites and Sponsors Are Adapting to Clinical Trial Budget Cuts
July 1st 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how clinical trial sites and sponsors are responding to funding constraints by turning to telemedicine, cost-containment strategies, and increased reliance on industry-sponsored research.
How Funding Cuts Are Undermining Patient Recruitment in Clinical Trials
June 30th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, explains how staffing reductions caused by clinical trial budget cuts are threatening patient recruitment and retention and warns of the long-term ripple effects on trial timelines and healthcare innovation.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.
Pfizer Reports Strong Phase III Results for Hympavzi in Hemophilia Patients with Inhibitors
June 26th 2025The Phase III BASIS trial found that once-weekly subcutaneous Hympavzi reduced treated bleed rates by 93% in patients with hemophilia A or B with inhibitors, offering a promising new prophylactic option for a population with limited therapeutic choices.
Although the SYMMETRY Phase IIb trial of the FGF21 analogue efruxifermin did not meet its primary endpoint at 36 weeks, extended 96-week data suggest potential benefits in fibrosis reduction and liver health in patients with compensated cirrhosis due to MASH, supporting continued evaluation in Phase III studies.
Detailed Phase IIIb STEP UP trial results presented at the 2025 ADA Scientific Sessions found that an investigational 7.2 mg dose of Wegovy (semaglutide) led to a mean weight loss of 21% in adults with obesity and no diabetes, showing the potential to expand dosing options in obesity management.
How CRO Partnerships Are Evolving to Meet Changing Industry Demands
June 25th 2025In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, explores how CRO partnerships are shifting to deliver greater efficiency, cost-effectiveness, and regulatory insight in response to tightening budgets and an increasingly complex clinical research environment.
MariTide Shows Up to 20% Weight Loss in Phase II Trial for Obesity, Type 2 Diabetes
In a Phase II trial, Amgen’s investigational therapy MariTide (maridebart cafraglutide) delivered significant, sustained weight loss of up to 20% in adults with obesity, with or without type 2 diabetes, alongside notable improvements in glycemic control, supporting its advancement to Phase III studies as a potential once-monthly treatment option.
How CROs Can Build Trust and Alignment with Pharma Partners
June 24th 2025In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, emphasizes the importance of proactive communication, strategic alignment, and cross-functional collaboration in establishing strong, effective partnerships between CROs and pharmaceutical companies.
2025 DIA Annual Meeting: The Importance of Early Patient Feedback in Digital Endpoint Development
June 24th 2025Brian 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.