US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch
Executive Summary
Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.
You may also be interested in...
US FDA Exploring Consortium To Develop Treatments For ‘Economically Infeasible’ Cancer Indications
The FDA could partner with industry, academia and advocacy groups to speed development of novel treatments for cancers that are not commercially viable.
Project Pragmatica: US FDA’s OCE Initiative Aims To Encourage Simple Clinical Trials
OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.
OCE ‘Project’ To Help Understand Trial Site Selection, Also May Inform Policy
Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.