I’m gonna apologize in advance for the ramble stream of thought:
Phase 1 subjects can get paid like $10,000 depending on the study because they’re required to live at the site for several weeks. For phase 2/3 compensation is way less. This is also because inclusion criteria is going to change throughout the study. So it’s not impossible to manage dynamic recruitment and associated reg processes like updating consent forms. But it will be a big culture change. It also makes site selection harder. Some sites are well set up to recruit healthy volunteers but don’t have the required patient population for a phase 3
And it’s not really clear what the benefit is. This might be my own ignorance at what happens between sponsor and FDA as I haven’t personally done that part. We already do what the FDA is aspiring for. I’ve done combined phase 1/2 studies that change with short notice based on results of phase 1 portion. And pharmacovigilance teams already monitor data in real time. So I’m just not sure what is being proposed here
Also, EHRs are an unreliable, unwieldy (due to hipaa), and extremely low quality data source. Updating EHRs with this capability will cost $$$. It’d be easier to do with esource vendors like CRIO, realtime, clinical conductor, but it would add site burden for no clear benefit