Dec 12, 2024 · Phase III CheckMate -8HW trial shows the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) significantly improved progression-free survival and overall response rates in patients with microsatellite-instability–high or mismatch …

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 ...

Dec 9, 2024 · Webinar Date/Time: Wed, Jan 22, 2025 11:00 AM EST. This webinar will focus on key data trends reshaping clinical trials, providing insights into how these innovations can be leveraged to meet current challenges and future demands.

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 ...

Nov 4, 2024 · In a video interview with Applied Clinical Trials, Jay Park and Rebecca Metcalfe of Core Clinical Sciences discussed their recent article published in JAMA titled, “Diversity Action Plans in Clinical Trials.” In addition to key takeaways from the article, Park and Metcalfe discussed the FDA's new guidance for diversity action plans in clinical trials, the role of risk-based monitoring as a ...

Jan 16, 2025 · In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical trials.She also highlighted technological advancements, such as data interoperability standards like ICH M11 and CDISC, and how they are expected to streamline protocol development and support generative AI in 2025.

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.

Jun 14, 2024 · Findings from the Phase II MagnetisMM-3 trial (NCT04649359) showed a significant survival benefit with Elrexfio (elranatamab-bcmm) in patients with heavily pretreated relapsed or refractory multiple myeloma (RRMM). 1 Elrexfio, a B-cell maturation antigen (BCMA)-CD3-targeted bispecific antibody, was granted accelerated approval by the FDA in August 2023 to treat patients with RRMM who were ...

Nov 6, 2023 · From the emergence of big data analytics to huge advances in precision therapies and trial technologies, the world of clinical research has transformed in recent years, leading to closer and more strategic partnerships between sponsors and …

Jun 26, 2024 · Treatment with tirzepatide (Zepbound and Mounjaro; Eli Lilly) was found to improve sleep-related patient-reported outcomes, as well as apnea–hypopnea index (AHI) scores, body weight, hypoxic burden, high-sensitivity C-reactive protein (hsCRP) concentration, and systolic blood pressure in patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 1 These data from the Phase ...