News

At 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.

Updated results from the Phase II RedirecTT-1 trial show that the dual bispecific antibody regimen of Talvey and Tecvayli delivers deep, lasting responses in patients with triple-class exposed relapsed or refractory multiple myeloma and true extramedullary disease.

In 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.

The 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.

AI as an accelerator for data-centric, process-centric, and human-centric clinical research.

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.

In 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.

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.

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.

In 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.

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.

How human-centered AI that is focused on customer, user, and employee experience can drive real transformation in clinical trials and beyond by aligning intelligent technologies with the people who use them.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, shares insights on how sponsors and CROs can cultivate a “one team” mindset by setting the right leadership tone, encouraging collaboration, and leveraging team-building strategies to drive clinical trial success.

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.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, shares why clear communication, strong leadership, and cultural alignment are essential to building effective partnerships between CROs, sponsors, and other stakeholders in clinical research.

New Phase III data published in The New England Journal of Medicine show elinzanetant, a nonhormonal dual NK-1/NK-3 receptor antagonist, significantly reduced vasomotor symptoms, improved sleep, and enhanced quality of life for women undergoing endocrine therapy for HR-positive breast cancer.

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.

In this video interview, Judith Ng-Cashin, MD, chief medical officer, Novotech, explains why seamless collaboration between CROs and sponsors is critical to advancing clinical trials, and reflects on Novotech’s recognition as Citeline CRO Partnership of the Year.

Primary results from the Phase II TRANSCEND FL trial show Breyanzi (lisocabtagene maraleucel) achieved a 95.5% response rate and durable efficacy in relapsed or refractory marginal zone lymphoma, supporting its potential as a transformative CAR T-cell therapy.

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.

In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, reflects on the importance of leadership to drive progress in clinical research amid evolving regulatory and funding challenges.

As wearable ECG technology advances, cardiac safety studies in clinical trials are evolving to capture richer, continuous heart data while reducing patient burden.

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.

In an interview with ACT senior editor Andy Studna at the 2025 DIA Global Annual Meeting, Carie Pierce, SVP, global head of growth & business development, DIA, shares her perspective on the progress of international regulatory initiatives like Project Orbis and highlights the industry’s renewed focus on scientific integrity amid global challenges.