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 populations and those in geographically or economically constrained areas.
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 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 ...
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 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.
Enhancing eCOA Through AI: A Look Ahead to 2025
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 …
Teva Shares Positive Phase III Data of Schizophrenia Injectable TEV …
Nov 4, 2024 · Teva has shared results from the Phase III SOLARIS (NCT05693935) clinical trial of TEV-'749 in adult patients diagnosed with schizophrenia. The subcutaneous long-acting injectable demonstrated significant improvements in social functioning and quality of …
Talzenna Plus Xtandi Shows Significant Overall Survival …
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 ...
The Roles of Central and Local Labs in Clinical Trials
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.
Regulatory CMC: Enhancing Biologics Development
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 ...
Building Relationships in Clinical Research
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.
Creating Strategic Relationships: The Changing Face of Contract ...
Nov 6, 2023 · From the emergence of big data analytics to huge advances in precision therapies and trial technologies, the world of clinical research has transformed in recent years, leading to closer and more strategic partnerships between sponsors and …