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 ...

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 …

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.

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.

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 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.

Nov 6, 2024 · Results from the STEP 9 trial (NCT05064735) show that patients with obesity administered once-weekly semaglutide experienced a significant reduction in knee osteoarthritis pain and body weight with improved physical function. 1,2 These results, published by The New England Journal of Medicine, suggest that the impact of semaglutide on weight reduction may help patients avoid the use of non ...

Dec 1, 2024 · Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.

Jan 23, 2011 · Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.

Oct 3, 2024 · Arcus Biosciences has announced a clinical trial collaboration agreement with AstraZeneca to evaluate casdatifan (AB521), Arcus’s investigational HIF-2a inhibitor, alongside volrustomig, AstraZeneca’s investigational PD-1/CTLA-4 bispecific antibody in patients with clear cell renal cell carcinoma (ccRCC).