Rybrevant Plus Lazcluze Shows Over One-Year Survival Boost in …
Jan 7, 2025 · Topline results from the Phase III MARIPOSA trial (NCT04487080) show the combination of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) produced a …
The CRA of the Future: From ‘Road Warrior’ to Site ‘Owner’
Feb 13, 2024 · The role of the clinical research associate (CRA) is fundamentally important to the success of clinical trials. However, this role is undergoing significant transformation due to the …
Cabozantinib Shows Significant Progression-Free Survival Benefits …
Sep 20, 2024 · Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq) produced a significant improvement in progression-free …
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 …
Enhancing eCOA Through AI: A Look Ahead to 2025
Dec 12, 2024 · The integration of artificial intelligence (AI) and machine learning (ML) into electronic clinical outcome assessment (eCOA) technologies promises to revolutionize how we …
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A New Regulatory Road in Clinical Trials: Digital Twins
Sep 12, 2024 · In recent decades, the complexity of clinical development has grown considerably. One study found that in the last decade, the average complexity score across all trials has …
Spotlight on Open-Label Extension Studies - Applied Clinical Trials
Jul 1, 2006 · Open-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study …
Phase III Trials Show Long-Term Efficacy of Cobenfy Treating …
Nov 1, 2024 · Data from a pair of Phase III trials presented at the 2024 Psych Congress demonstrate that Cobenfy (xanomeline and trospium chloride) maintained long-term efficacy in …
FDA Finalizes Decentralized Clinical Trial Guidance
Nov 25, 2024 · The FDA's guidance is part of a broader effort to modernize clinical trials, improve efficiency, reduce participant burden, and expand access, particularly for underrepresented …