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 ...
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 ...
Applied Clinical Trials-11-01-2024
Nov 1, 2024 · Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
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.
Phase III ALIGN Trial Shows Atrasentan Significantly Reduces ...
Nov 7, 2024 · An interim analysis of the Phase III ALIGN trial (NCT04573478) demonstrated that 36 weeks of treatment with atrasentan significantly lowered proteinuria in patients with high-risk immunoglobulin A (IgA) nephropathy with a favorable safety profile compared to placebo, according to data published by The New England Journal of Medicine. 1,2 The trial is ongoing to determine the longer-term ...
Better Qualification Strategies, Better Patient Recruitment Outcomes
Oct 14, 2024 · Modern clinical trials are more complex than ever, and one significant reason is the increased focus on patient engagement. Incorporating a patient engagement platform into your clinical trial enhances the patient experience and can lead to more successful trials with stronger, more reliable outcomes.
2025 Trends: Investing in Clinical Data
3 days ago · In a recent video interview with Applied Clinical Trials, Dipanwita Das, CEO & co-founder at Sorcero, discussed advancements and future trends in clinical trials.Key challenges include high costs, long timelines, lack of diversity, and rigid protocols. Das highlighted technological advancements such as AI, real-time monitoring, and historical data analysis, which are all expected to optimize ...
Phase III THARROS Trial to Evaluate Impact of Breztri Aerosphere …
Mar 14, 2024 · AstraZeneca has announced plans to launch the Phase III THARROS trial to evaluate Breztri Aerosphere—a single-inhaler, fixed-dose, triple-combination therapy—in patients with chronic obstructive pulmonary disease (COPD) who have an elevated cardiopulmonary risk, regardless of prior exacerbation history. 1 In addition, the company announced that the first patients have been dosed in the ...
Spotlight on Open-Label Extension Studies - Applied Clinical Trials
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 …