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.

Jan 16, 2025 · In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical trials.She also highlighted technological advancements, such as data interoperability standards like ICH M11 and CDISC, and how they are expected to streamline protocol development and support generative AI in 2025.

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 ...

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 ...

Sep 16, 2024 · Final efficacy and safety data from the Phase III CheckMate -067 trial (NCT01844505) demonstrated durable survival improvements over 10 years with the combination of first-line Opdivo (nivolumab) with Yervoy (ipilimumab) or Opdivo monotherapy compared with Yervoy monotherapy in patients with previously untreated advanced or metastatic melanoma. 1-3 The results, published by The New England ...

Jan 14, 2025 · Updated data from the Phase III TALAPRO-2 trial show that the combination of Talzenna (talazoparib) and Xtandi (enzalutamide) significantly improves overall survival in patients with metastatic castration-resistant prostate cancer regardless of mutation status.

Feb 13, 2024 · The role of the clinical research associate (CRA) is fundamentally important to the success of clinical trials. However, this role is undergoing significant transformation due to the changing dynamics within the clinical research industry.

Jan 17, 2025 · In a recent video interview with Applied Clinical Trials, Kimberly Tableman, founder & CEO, ESPERO, discussed the challenges and trends in protocol development for clinical trials.She also highlighted technological advancements, such as data interoperability standards like ICH M11 and CDISC, and how they are expected to streamline protocol development and support generative AI in 2025.

Oct 14, 2024 · Dr. Peter Wahl, MLA, MS, ScD, VP and Global Head of Scientific Affairs at CorEvitas, part of the PPD™ clinical research business of Thermo Fisher Scientific, discusses the critical role of protocol-driven registries in generating regulatory grade RWE to serve multiple and evolving evidence needs across the drug development life cycle.

Jul 1, 2018 · An ever-changing regulatory framework is the biggest challenge for multinational clinical trials today. Back in 2009, the clinical research world welcomed the launch of the European Medicines Agency (EMA) and FDA good clinical practice (GCP) initiative that set the goal “to increase globalization of clinical trials” and improve cooperation with the non-EU regulatory bodies to standardize ...