IDDI starts Research on Statistical Method for individualization of Therapy
Clinical services provider International Drug Development Institute (IDDI) is forming a research collaborative into the use of a new statistical method called Generalized Pairwise Comparisons (GPC). The objective of the collaborative is to establish proof of the concept that the GPC method can complement traditional methods for the design, analysis and interpretation of clinical trial results in regard to accounting for multiple endpoints at once and ranked in order of priority. In addition to IDDI’s lead, the collaborative includes Bristol-Myers Squibb, the European Organization for Research and Treatment of Cancer (EORTC), the Université Catholique de Louvain and the University Hospital and Cancer Center of Lyon.
Read the full release 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.
