Applied clinical trials, 2018-12-01, Vol.27 (12), p.3-3
CDER and the FDA have backed up their support of basket trials, master protocols, and more collaborative types of trials by initiating for comment on Oct. 1 the draft guidance, "Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics." FDA also put forth for comment its draft guidance, intending to replace one from 2010, "Adaptive Designs for Clinical Trials of Drugs and Biologics," which provides direction on "the basic principles for designing, conducting, and reporting the results from an adaptive clinical trial." In another article from Bloomberg Law, bit.ly/2FU5lZf, FDA Commissioner Scott Gottlieb hinted that CROs may need to reflect on their own processes that may be unnecessarily bloating drug development costs without adding value.
Clinical trials ; Design ; Economic aspects ; Gottlieb, Scott ; Laws, regulations and rules ; Political aspects
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