DCRI and SAS Open Data to Researchers
A collaboration between The Duke Clinical Research Institute (DCRI) analytics, business intelligence and data management software and services provider SAS will give researchers access, analytics and data management tools to its database that includes 45 years of cardiovascular patient data collected by the Duke University Health System, including de-identified records for patients; data from more than 100,000 procedures; treatment histories, and more. The information can be used to test clinical hypotheses, develop clinical trial protocols and help researchers assess long-term outcomes and assess time trends. The DCRI and SAS are constructing a data governance plan to ensure the reliability of the data sets and to process requests as efficiently as possible. Researchers can apply for access to the data sets at soar.dcri.org. Read the full release here
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.
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.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Putting Collective Insights Into Action to Advance Cancer Care: Key Examples From ASCO 2025
June 27th 2025At ASCO 2025, clinical operations leaders gained critical insights into how AI tools, bispecific antibodies, and evolving treatment paradigms are reshaping trial design, endpoint selection, and patient stratification.
