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 · Pilot trial shows that a user-friendly electronic patient-reported outcome (ePRO) monitoring system significantly improves patient-centered cardiovascular care by enhancing patient-physician communication, increasing clarity in treatment explanations, and empowering patients with better knowledge of their conditions.

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 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 ...

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.

Oct 29, 2024 · Use of decentralized approach in a Phase 1 pharmacokinetic trial shows the ability to enable remote data collection and monitoring, which could improve patient access and enhance the efficiency of clinical research.

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 ...

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

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 ...

Sep 11, 2024 · An experienced regulatory CMC team can provide expertise and support to quickly obtain the relevant GMO approvals in the different countries within the trial footprint without delaying first- patent-in targets by identifying and using the correct forms, e.g., the common application forms used in Europe, the investigator site-specific forms in the UK, or by preparing the documents for the ...