Trial details, page-19

Well the ann has come out locally now and I have to say:

- I'm not convinced on the 3 month time span. I know they then go open label. I know there are some who will say, almost conspiratorially, "it's like they're trying to make sure this gets over the line." I think it's great they're going for 180 participants (though that's in line with expectations), but don't like that the trial parameters have changed from what was expected.

- I think going open label is an interesting decision and I wonder if it will have a motivating effect. After all part of the disincentives with trials is "all that work and we were on the placebo." Given the buzz trof supposedly has within the community I think this will get a positive response.

- I am intrigued as to how timings will work. Let's assume the trial takes a year to run. That's a complete guess based on the last Ph IIb trial which sprinted along quite quickly. Imagine they can initiate all participants in a 9 month period. So say 10 trial sites that means onboarding a patient every fortnight and each site carrying 6 on the books at any one time. Sounds easy doesn't it but trials always run slow.

So patient 1 finishes and receives trof for a while (3 months? 6 months?) while other patients enrol. What happens to the last patient in the trial? Does the trial close off, analyse data and report results ASAP or do they wait until the last open label patient finishes?

Well the main thing at the moment is that the trial starts on time.