Thank you.
Clinical trials are a key aspect of the new framework. This actually is a very international discussion as well.
A number of features will be uniquely Canadian. One is our geography. I think it's quite right to say that the disparity of where patients live and whether they have access to a trial site will be a uniquely Canadian factor. That's one of the reasons why we need good patient input and physician input at that front end when we're designing the trial site. We are reviewing the clinical trial regulations as well, to make sure that the definition of the trial site, for example, is not prohibiting being able to do some virtual work and reporting.
There's another important discussion that we're having, largely through our oncology researchers, our cancer researchers. They've talked about really being able to focus in the trial on the main things and really understanding the burden of paperwork and the innovation cycle, not dropping any of the safety, but really understanding what the basics of the trial need to be. We're having meetings to discuss our way through that. That, too, is also an international discussion. If you have multiple research ethics boards, and you have to file and file and file in each place that you're doing a study, that can be hard when you only have a few numbers.
In terms of that, we're really looking. Some of it's formative. Some of it is well defined internationally, but there are some new sciences gathering around trial size and being able to deal with small populations in regard to how you put that together pre-market and then how you follow it out into the market, in order to make sure that some of the assumptions you're making before you market are real in terms of both the benefit and the safety.
On the safety point, as regulators, it's more and more common that the moment we see a signal it's very important to make sure that globally we understand that. Within the framework, we're proposing to have fairly immediate updates, obligated in regulation, to tell us if there's anything is happening in any other jurisdictions. If you're running a trial or if you have a licence to sell in Canada, it would be a feature of the system to make sure that the constant flow of reporting on safety is really there. If in Canada we start to see safety signals when we get case reports, though, we need to feed that rapidly into the global understanding as well. We're all working together commonly.
Again, this is one area where there's a lot of cooperation among regulators. At least for the designation, it's the only place I'm aware of where the U.S. and the Europeans have a common application form. That's a really important thing from an innovation point of view.