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.
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.
First Patient Dosed in Phase III Trial of Enhertu as First-Line Treatment for Endometrial Cancer
June 10th 2025In combination with rilvegostomig or Keytruda, Enhertu will be evaluated versus chemotherapy in the DESTINY-Endometrial01 study for the treatment of patients with HER2-expressing, mismatch repair proficient primary advanced or recurrent endometrial cancer.
