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.
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US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas
Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.
Clinical Trial Diversity Campaign Distracting From Health Equity Problems, Califf Says
The FDA commissioner says that improving health disparities would fix the lack of diversity in clinical trials.
Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus
US FDA cancer chief Rick Pazdur plans to send industry to ‘rehab’ with Project Frontrunner, which will push for development of cancer drugs in randomized controlled trials in earlier disease. Goal is to reduce time of uncertainty between accelerated approval and confirmatory evidence.