Applied Clinical Trials Digital Edition - October 2009

Results from the Phase III CAHtalyst show that patients treated with Crenessity for classic congenital adrenal hyperplasia achieved and maintained lower, more physiologic glucocorticoid doses while keeping key adrenal biomarkers at or below baseline levels.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Why a fundamental reimagining of how clinical studies operate is still necessary to achieve a true paradigm shift—and shed the cycle of reliance on incremental gains.

The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.

In the P304 Phase III study, Moderna’s mRNA-1010 demonstrated a 26.6% relative efficacy over a standard-dose flu vaccine in adults aged 50+, showing consistent protection across strains and age groups.