FDA Expands RWE Partnership with Brigham and Women’s Hospital and Aetion

Results from the Phase III FORTITUDE-101 trial showed that bemarituzumab combined with chemotherapy demonstrated both statistical significance and clinical relevance in previously untreated patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction cancer who are FGFR2b-positive and HER2-negative.

In 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.

How clinical operations teams can close the gap between controlled trial results and real-world adoption by generating evidence in broader, more representative patient populations.

New data from the pivotal GEMZ study show significant seizure reduction with adjunctive fenfluramine in CDKL5 Deficiency Disorder.

The 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.