Better Clinical Trial Safety Data Would Aid Benefit/Risk Analysis – DIA Europe Panel
This article was originally published in The Pink Sheet Daily
More work needs to be done on benefit/risk assessments before Phase II/III, industry reps say.
You may also be interested in...
A recent request for proposals may signal a shift in FDA's approach to risk/benefit analysis and views on outcome measures, a move some see as bringing more transparency while also shielding the agency from criticism
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.