Pluristem Therapeutics Inc (PSTI)

[FDApproved]

Is She Talking About Cell Therapy....Pluristem ?



The clinical trials system is "broken" and there needs to be new ways to collect and utilize patient data, Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, told a workshop on real world evidence (RWE) at the National Academies of Sciences, Engineering, and Medicine on Wednesday.

The comment came at the end of Woodcock's talk in which she also noted that use of master protocols (ie. protocols for trials that look at multiple therapies in a single disease or a single treatment in multiple diseases) and the development of new clinical trial networks "need to be the future."



http://www.raps.org/Regulatory-Focus/News/2017/09/20/28500/FDAs-Woodcock-The-Clinical-Trials-System-is-Broken/