hoping that maybe somebody could give a potted history and an overview of the Critical Path Initiative?
Rachel Behrman (RB): I can start with that one. The Critical Path Initiative, which the FDA launched a little over four years ago, is a concerted effort to modernise the tools necessary for developing, evaluating, manufacturing and using FDA-regulated products. So it’s a concerted modernisation and innovation initiative. SC: We’ve heard quite a bit recently, especially on the Internet, about the Clinical Trials Transformation Initiative (CTTI); could somebody explain to me the reasons behind why that was established? Robert Califf (RC): I can take that one and get the discussion started. Like many cooperative efforts, there are probably a lot of reasons why people would want to join it; but I think the main reason that we were interested in joining with the FDA, is that there is a great degree of frustration about the inefficiency of doing clinical trials today. We’re increasingly, inappropriately hearing from many sectors of society, that we need better evidence upon which to base dec
Related Questions
- What will the effect of these projects be on the medical product development process? How will the Critical Path Initiative help bring new treatments to patients?
- I have some ideas for modernizing medical product development, how can I get involved in FDAs Critical Path Initiative?
- hoping that maybe somebody could give a potted history and an overview of the Critical Path Initiative?