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.
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 ...
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.
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 ...
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 Evolution of CRO and Sponsor Relationships - Applied Clinical …
Nov 16, 2023 · The landscape for clinical trials is ever evolving. 1 Adaptive trial designs, decentralized, and hybrid trials are becoming more prevalent, particularly in light of the COVID-19 pandemic. 2 Regulatory changes in the US and abroad are constant and inevitable. As clinical trials change, the relationships between contract research organizations (CROs) and sponsors have evolved as well.
Applied Clinical Trials Online
January 16th 2025. An updated long-term analysis of the Phase III KATHERINE trial confirms that adjuvant treatment with Kadcyla (trastuzumab emtansine) significantly improves overall survival and long-term invasive disease–free survival compared to trastuzumab monotherapy in patients with HER2-positive early breast cancer with residual invasive disease.
Building Relationships in Clinical Research
Oct 29, 2024 · In this video interview, Jimmy Bechtel, vice president, site engagement, SCRS, discusses the importance of communication between CROs, sponsors, and sites.
Applied Clinical Trials
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
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 …