Jan 7, 2025 · Topline results from the Phase III MARIPOSA trial (NCT04487080) show the combination of Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) produced a statistically significant improvement in overall survival (OS) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or L858R substitution ...

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 changing dynamics within the clinical research industry.

Sep 20, 2024 · Results from the Phase III CABINET trial (NCT03375320) demonstrated that cabozantinib (Cabometyx, Cometriq) produced a significant improvement in progression-free survival (PFS) compared to placebo in patients with advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic neuroendocrine tumors (epNET). 1,2 These findings, presented at the 2024 European Society for Medical ...

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.

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 collect, analyze, and utilize patient data in clinical trials.

Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.

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 risen by more than 10%—with the biggest complexity increase seen in oncology trials, followed by Crohn’s disease, multiple sclerosis, and stroke. 1 But despite the backdrop of complexity, the pressure to drive down ...

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 typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study …

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 adult patients with schizophrenia over 52 weeks, producing significant improvements in symptoms and quality of life with minimal adverse effects (AEs). 1 Cobenfy, formerly called KarXT, is an oral muscarinic antipsychotic ...

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 populations and those in geographically or economically constrained areas.