This document starts to get at the kind of issues the FDA has and (IMO) explains how Dr.G. sees the issues. IMO we must see more use of science/RWE facts and enable more flexibility in how a protocol deals with new information developed during a trial.
My interpretation is he wants sponsors and industry to harmonize more around the science and the data/results when it makes sense to speed things up. He says the FDA hands are tied by industry, which must change. I think he looks for more cross pollination.
The model of live and die by the rule of the TRIAL should be changed to let the science do the talking. He also favors use of devices/RWE and EHR as examples for progress. (I read devices as code for ERP such as Actigraph in use in our PDD) .
Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations. In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable. We appreciate that scientific and technical complexity is a real and ongoing challenge, but industry and academia also need to invest in and leverage these approaches and develop new incentives that reward collaboration and data sharing across the clinical research enterprise. New research paradigms are needed to break down barriers between real world data and clinical research, so that evidence can be shared rapidly to improve both domains across a learning health care system.For instance, more trials can incorporate data from electronic health records, and adopt electronic informed consent, to enroll more patients in clinical trials closer to where they live and work. This can reduce barriers to clinical trial participation and accelerate researchers’ ability to ask and answer important questions.
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