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.
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.
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 ...
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 ...
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 ...
Revolutionizing Oncology: Insights on the FDA’s Project Optimus …
Sep 20, 2024 · As oncology drugs advance from cytotoxic chemotherapies to targeted treatments, newly finalized guidance from the FDA promotes early identification of optimal drug doses. 1 Titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases,” the guidance reaffirms the agency’s thinking about how sponsors should evaluate the balance ...
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 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.
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 …