News

Policy change by the Trump administration now allows the agency to post public notices in the Federal Register and advertise meetings on scientific research groups.

Phase III PRESTIGE-AF trial shows that direct oral anticoagulants significantly lower the risk of ischemic stroke in survivors of intracerebral hemorrhage (ICH) with atrial fibrillation, but increased the risk of recurrent ICH and major bleeding complications.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the importance of open dialogue during risk assessments.

How targeted AI can improve the performance of clinical trials.

The Phase III GEMSTONE-303 trial demonstrated that sugemalimab plus chemotherapy significantly improves overall survival and progression-free survival compared to chemotherapy in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with PD-L1 CPS ≥5.

In this video interview, Vera Pomerantseva, director of product management, RBQM, eClinical Solutions, highlights FDA’s recent protocol deviations guidance and how it reinforces previous recommendations from industry.

Following initial positive results shared by Teva and Sanofi in December 2024, new data shows duvakitug (TEV’574/SAR447189) achieved higher rates of clinical remission compared to placebo in the advanced therapy-experienced subgroup.

The combination of Opdivo plus Yervoy produced significant Phase III trial results in the first-line treatment of patients aged 12 and older with unresectable or metastatic MSI-H/dMMR colorectal cancer.

In this video interview, Pomerantseva, director of product management, RBQM, eClinical Solutions, discusses the new guidance and its level of detail on the different types of protocol deviations.

In this video interview, Dipanwita Das, CEO & co-founder, Sorcero; Sujay Jadhav, CEO, Verana Health; and Kimberly Tableman, founder & CEO, ESPERO, highlight areas around clinical data that could have a large impact on the industry in 2025.

Data from the Phase III EMERGE trial show treatment with Symbravo provided more rapid and sustained migraine relief with improved quality of life in patients who previously had an inadequate response to CGRP treatments.

Tremfya could become the first IL-23 inhibitor with fully subcutaneous induction and maintenance options in the treatment of moderately to severely active ulcerative colitis.

In this video interview, Dominique Demolle, CEO of Cognivia, discusses how understanding the patient journey from the very beginning of a study can help mitigate risk and improve patient centricity.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Graham Clark, CEO, Phastar, discusses key objectives for attending SCOPE, the rise of real-world evidence, and partnerships critical to improving the success of clinical trial outcomes.

The first prespecified interim analysis of the Phase III AMPLIFY trial found that fixed-duration Calquence (acalabrutinib) plus venetoclax, with or without Gazyva (obinutuzumab), significantly improved progression-free survival compared to chemoimmunotherapy in fit patients with previously untreated chronic lymphocytic leukemia.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Sebastien Coppe, CEO, One2Treat, talks challenges faced by startups in advancing clinical trial innovation.

In this video interview, Dominique Demolle, CEO of Cognivia, talks artificial intelligence/machine learning and its potential in gathering patient data.

In this video interview, Dominique Demolle, CEO of Cognivia, highlights how patient non-adherence can increase trial timelines and incur additional costs.

The final analysis of the Phase III CheckMate -816 trial confirmed a statistically significant overall survival benefit for patients with resectable non-small cell lung cancer treated with neoadjuvant Opdivo (nivolumab) plus chemotherapy.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Samuel Salvaggio Senior Trial Design Lead, One2Treat, discusses partnerships that remain vital for guaranteeing success in clinical trial efficiency.

The ongoing evolution of real-world evidence from a novel concept to a cornerstone of modern medical research signifies its growing importance and vast potential to improve personalized medicine, overall healthcare outcomes, and eventually democratization of scientific facts by general accessibility.

In this video interview, Dominique Demolle, CEO of Cognivia, discusses challenges that sponsors are currently facing with adherence and some strategies that can help address them.

Machine learning can help investors dive deeper into trial data to evaluate the true potential of an asset and uncover new hidden opportunities.

In an interview with Applied Clinical Trials Associate Editor Don Tracy, Samuel Salvaggio, Senior Trial Design Lead, One2Treat, discusses the company's main goals for attending the SCOPE Summit, including patient centric trial design.

Five-year data from the POETYK PSO long-term extension trial confirm the sustained efficacy and safety of Sotyktu (deucravacitinib) for moderate-to-severe plaque psoriasis, with patients maintaining high clinical response rates and no new safety concerns identified.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Rajneesh Patil, vice president, digital innovation, IQVIA, highlights the impact of artificial intelligence/machine learning in improving outcomes and maintaining safety with its implementation.

In an interview with ACT senior editor Andy Studna at SCOPE Summit, Drew Garty, chief technology officer, clinical data, Veeva Systems, discusses clinical data trends for 2025 and simplifying management processes.

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.