TrialScope Tackles Issue of “Sharing Clinical Trial Results With Patients”

The FDA’s Oncologic Drugs Advisory Committee voted against an application for Columvi (glofitamab) plus GemOx for relapsed/refractory diffuse large B-cell lymphoma due to concerns about the applicability of multiregional trial data to the US patient population.

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.

A pragmatic approach to streamlining technology and innovating processes will help advance clinical data management.

Improving access while maintaining a high level of research.

The global, randomized IDeate-Esophageal01 study will evaluate ifinatamab deruxtecan, a B7-H3–targeted antibody-drug conjugate, versus physician’s choice of chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma following progression on platinum-based chemotherapy and immune checkpoint inhibitors.