Applied Clinical Trials-12-01-2024
Dec 1, 2024 · Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
The Strategic Emergence of Site Networks in Clinical Research
Oct 14, 2024 · These attributes can help sponsors assess the potential of a site or network to meet the specific needs of their trials. For example, a site with a robust infrastructure and centralized operations may be better suited for large-scale, multi-site trials, while a smaller, independent site may be ideal for niche studies requiring specialized expertise.
Talzenna Plus Xtandi Shows Significant Overall Survival …
Oct 10, 2024 · The combination of Talzenna (talazoparib; Pfizer) plus Xtandi (enzalutamide; Astellas and Pfizer) produced a statistically significant improvement in overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) regardless of mutation status, according to results from the Phase III TALAPRO-2 trial (NCT03395197). 1,2 Pfizer noted that these results represent the ...
The Roles of Central and Local Labs in Clinical Trials
Nov 11, 2024 · In a recent interview with Applied Clinical Trials, Kelli Aufderheide, director, laboratory decentralized trial solutions, IQVIA Laboratories, discussed the benefits of central and local labs for clinical trials.Central labs offer harmonized test menus, standardized data collection, and global reach, ensuring consistent results across labs.
Phase III ALIGN Trial Shows Atrasentan Significantly Reduces ...
Nov 7, 2024 · An interim analysis of the Phase III ALIGN trial (NCT04573478) demonstrated that 36 weeks of treatment with atrasentan significantly lowered proteinuria in patients with high-risk immunoglobulin A (IgA) nephropathy with a favorable safety profile compared to placebo, according to data published by The New England Journal of Medicine. 1,2 The trial is ongoing to determine the longer-term ...
Applied Clinical Trials Online
January 13th 2025. Results from the TROPION-Lung05 and TROPION-Lung01 clinical trials show the promise of datopotamab deruxtecan, a novel TROP2-directed antibody-drug conjugate, for the treatment of locally advanced or metastatic EGFR-mutated non-small cell lung cancer.
Novel Once-Weekly HIV Treatment with Islatravir and Lenacapavir …
Oct 21, 2024 · The novel combination of islatravir (Merck) and lenacapavir (Gilead) maintained high rates of viral suppression in virologically suppressed adults with HIV after 48 weeks of treatment, according to the results of a Phase II clinical trial (NCT05052996) presented during at ID Week 2024. 1,2 Trial investigators noted that these findings could lead to the combination therapy becoming the first ...
Tulisokibart Shows Superior Efficacy in Achieving Clinical …
Oct 2, 2024 · Tulisokibart (Merck) showed superior efficacy to placebo in achieving clinical remission in patients with moderately to severely active ulcerative colitis (UC), according to data from the proof-of-concept Phase II ARTEMIS-UC trial (NCT04996797) published by The New England Journal of Medicine. 1,2 The investigational humanized monoclonal antibody is currently in development to treat immune ...
The Evolution of Real-World Evidence: Moving Beyond Claims …
Oct 1, 2024 · The pharmaceutical industry is facing a challenging landscape where the cost of bringing new drugs to market is rising and the return on investment (ROI) is sharply declining.
Keytruda Significantly Improves Event-Free Survival in Phase III …
Oct 9, 2024 · Keytruda (pembrolizumab) produced a significant improvement in event-free survival (EFS) and major pathological response as a perioperative treatment for resected, locally advanced head and neck squamous cell carcinoma, according to data from the Phase III KEYNOTE-689 trial (NCT03765918). 1,2 With these results, KEYNOTE-689 becomes the first Phase III trial to show statistically significant ...