I guess I'm a believer in mandatory reporting as a component. Partially why I put my energy into supporting the drug research and effectiveness network is it would be the backbone that would support researchers like Bruce, doing what I would call communities of practice; that is, we would use the surveillance methodologies that are already in place to drill into practice communities--whether it's birth control providers, if we think about EVRA and the patch, cancer communities, if we're thinking about cancer--so that the providers that are working with those drugs understand their engagement and involvement in this post-marketing effort. It doesn't mean that we don't have a general information database.
But the other side--and this is what I call phase two if I had a work plan in front of me--is to build communities of practice, and I'm using those words, because I think it is about reflection, discussion, and having a closed feedback loop. It's what we knowledge-brokers call communities of practice, because that gets to the specificity and the richness of the data, but it allows us a sentinel function. When you put a canary down a coal mine, it doesn't tell you what killed it. It just tells you it's dead. Well, in a similar way, we need a canary methodology--that's what adverse drug reporting in a broad way is--but we need to support these communities of practice that will actually do the day-to-day detailed development and the rich analysis that's needed.
I infer that Dr. Carleton's work is also around saying we need some of the biologics to help us inform that. That should be part of the road map plan too, with the sex and gender analysis.