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 ...
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.
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.
Key Takeaways From the 2024 DTRA Annual Meeting
Dec 12, 2024 · In a recent video interview with Applied Clinical Trials, Jane Myles, program director, Decentralized Trials & Research Alliance (DTRA), discussed trends and challenges in decentralized clinical trials (DCTs) including misconceptions and the rapid adoption of DCT elements.Myles also highlighted DTRA's initiatives on site adoption, operational planning, and the integration of digital health ...
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 …
Novel Once-Weekly HIV Treatment with Islatravir and Lenacapavir …
Oct 21, 2024 · The novel combination of islatravir (Merck) and lenacapavir (Gilead) maintained high rates of viral suppression in virologically suppressed adults with HIV after 48 weeks of treatment, according to the results of a Phase II clinical trial (NCT05052996) presented during at ID Week 2024. 1,2 Trial investigators noted that these findings could lead to the combination therapy becoming the first ...
Estimand Framework: What it is and Why You Need it
Feb 27, 2020 · According to section A.6 of the ICH guidance 1, the clinical trial protocol should very clearly specify a primary estimand that addresses the primary study objective.Estimands for secondary trial objectives that support regulatory approval …
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 ...
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 …