Cycle Time Reduction Remains Elusive
KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times.
KMR Group reports that the duration of clinical trials continues to hold steady or increase despite ongoing efforts by biopharmaceutical companies to reduce cycle times. KMR Group assessed cycle time trends for more than 6,000 Phase II/III clinical trials using proprietary industry data across 27 companies going back to 2005. The analysis focused on clinical trials across all therapeutic areas. KMR defines total cycle time as the interval from Protocol Approval to Clinical Trial Report (PA-CTR). The analysis reveals that both Phase II and III trials have increased significantly over the last 10 years and continue to rise. Phase III trials took a median 35.7 months for industry in 2005-07 and takes 42.9 months in 2012-14.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In 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.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The 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.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.
