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.

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 ...

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 ...

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.

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.

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 ...

Feb 1, 2003 · Conference keynote explores the long-term vision for integrating clinical research and care by 2035, including progress driven by digital advancements, artificial intelligence, and evolving regulatory frameworks.

Mar 1, 2006 · Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. To ensure clinical data accuracy and integrity, it is necessary to thoroughly review these data, to assess the validity of outlying data points, and to carefully document query identification and resolution throughout a study's duration.

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 ...