New Consensus Recommendations Announced for Standardized Imaging Protocol
The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) announced a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help assess if a new treatment is effective.
The Jumpstarting Brain Tumor Drug Development Coalition (JBTDDC) announced a new consensus protocol for magnetic resonance imaging (MRI) in brain tumor clinical trials to help assess if a new treatment is effective. A standardized protocol will encourage the brain tumor drug development by providing an accepted way to capture imaging information essential to the evaluation of future treatments
As is the case across all oncology clinical trials, Overall Survival (OS) is the “gold standard” measurement of investigational brain tumor therapies’ effectiveness. However, OS trials are lengthy and expensive. Therefore, the field of neuro-oncology has a long-standing interest in using alternative endpoints that use imaging to measure tumor progression and response to determine the relative value of an investigational treatment.
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.
