A recently published study from Tufts’ Center for the Study of Drug Development and AiCure, an AI and advanced data analytics company focused on improving clinical trials, identified and quantified the scope of intentional non-adherence to clinical trial drugs. The study, entitled “Assessing the Scope and Predictors of Intentional Dose Non-Adherence in Clinical Trials,” consisted of nearly 260,000 anonymized dosing results, which were drawn from 2,796 study volunteers participating in 23 different clinical trials of nine psychiatric, neurological and neuromuscular diseases.
To see the findings, click here.
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.