ACT: What should industry stakeholders be keeping top of mind when implementing artificial intelligence (AI) into their workflows? Lacroix: When we started thinking, or when I was brought into the initiatives at…
Category: Medicine
Rybrevant with Leclaza Shows Significantly Improved Progression-Free Survival vs. Tagrisso Treating EGFR-Mutated Advanced NSCLC
Image credit: Sebastian Kaulitzki | stock.adobe.com The combination of Rybrevant (amivantamab-vmjw; Janssen Pharmaceutical) with Leclaza (lazertinib; Johnson & Johnson) produced significantly improved survival compared to Tagrisso (osimertinib; AstraZeneca) in the treatment of patients…
New Results From National Comprehensive Cancer Network Survey Show Drug Shortages are Impacting Clinical Trials
Image Credit: © Andrii Yalanskyi – stock.adobe.com The National Comprehensive Cancer Network (NCCN) has published new results for its latest survey on cancer drug shortages in the United States. This follows data…
Pediatric Patients with Eosinophilic Esophagitis Administered Dupixent Achieve Significant Improvements Across Multiple Disease Measures
Image credit: shidlovski | stock.adobe.com Phase III trial data published by The New England Journal of Medicine (NEJM) show the efficacy of Dupixent (dupilumab) treating eosinophilic esophagitis (EoE) in children from one to…
FDA Issues Draft Guidance on the Submission of Diversity Action Plans
Image Credit: © Jakub Krechowicz – stock.adobe.com The FDA has issued a draft guidance which provides details to medical product sponsors on submitting Diversity Actions Plans to support clinical studies. The guidance,…
Complexities in Data Management
ACT: What are some of the biggest challenges you are currently seeing with data management in clinical trials? Lacroix: Since I’ve been in industry for over 20 years, the complexity of protocols…
FDA Clears Adicet Bio’s IND Application for ADI-270 in Renal Cell Carcinoma, Phase I Study to Begin in 2024
Image Credit: © Crystal light – stock.adobe.com Adicet Bio has announced that the FDA has cleared its Investigational New Drug (IND) application to evaluate ADI-270, an armored allogeneic “off-the-shelf” gamma delta chimeric…
Results from Phase III Trials Show Eli Lilly’s Tirzepatide Reduces Obstructive Sleep Apnea Severity
Image Credit: © terovesalainen – stock.adobe.com Eli Lilly has announced results from its Phase III clinical trials of tirzepatide for the treatment of moderate-to-severe obstructive sleep apnea (OSA) in adults with obesity,…
Usage of Patient-Reported Outcomes in Blood Cancer Clinical Trials
Image Credit: © putilov_denis – stock.adobe.com In recent years, there has been a growing interest in the use of patient-reported outcomes (PROs) in clinical trials. When it comes to evaluating subjective symptoms,…
The Shift Toward Precision Medicine Requires Claims Data Insights
Healthcare today is evolving into precision medicine, or what the FDA refers to as personalized medicine. To stay competitive in the constantly shifting healthcare landscape, organizations across the healthcare ecosystem must embrace…