Oncology Trial Times On the Increase
KMR Group recently assessed the duration of oncology trials and found a steady rise
KMR Group recently assessed the duration of oncology trials and found a steady rise in late stage oncology cycle times in the last 10 years. KMR Group assessed cycle time trends for more than 4,100 oncology trials using proprietary industry data across 32 companies and found that Phase II oncology trials require about one additional year, compared to trials conducted a decade ago. Phase III trials are taking almost five years, which is one and a half years longer than trials in 2003-2005. KMR defines study duration as the interval from protocol approval to database Lock.
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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.
FDA Grants Priority Review to Merck’s sBLA for Winrevair After Early Success in ZENITH PAH Trial
July 2nd 2025Merck’s bid to update Winrevair’s label advances with FDA priority review, backed by Phase III ZENITH data showing a 76% reduction in major morbidity and mortality events in patients with pulmonary arterial hypertension.
