Regarding differences bw TRUST 1 and TRUST 2:...a couple of things I had picked up recently. First, from last CNDO CC, CEO said that Trust 2 (Europe) inclusion criteria prohibited any Crohn's drugs at all. Trust 1 did allow certain drugs (but i believe both excluded TNF inhibitors). Second, from bioinvest recent issue, I learned that Trust 2 did not do a colonoscopy to test for active Crohn's. Conversely, Trust 1(USA trial) did do a colonoscopy and was very careful to include only patients that they were very confident had active Crohn's.
I am looking for signs that Trust 1 has more likelihood of success than Trust 2 (i personally believe Trust 2, if successful, will achieve statistical significance by a relatively narrow margin).
Conclusion re fact 1: I don't know (anybody?)
Conclusion re fact 2: It is obviously harder to achieve a statistically significant improvement if you are perhaps measuring people that don't even have active Crohn's. So this is a positive in terms of chances of a favorable or overwhelmingly favorable Trust-1 result, which seems less likely for Trust-2.(IMO).
OTHER STUFF: I also had noticed in the past, but never seen any comment on, that the starting upper range of the CDAI of the patients is 100 points higher for Trust-1 than Trust-2. This is a positive in terms of design as it relates to primary endpoints. (Trust 1 PE is positive response 100, Trust 2 PE is remission= 100 for positive response if high range CDAI is 550 since for those upper patients 100 is a lower percentage of the starting CDAI. Also, for Trust-2 it is easier to get to
Yahoo hates me.
There is a chance that TRUST-1 p less than 0.05, and TRUST-2 p between 0.05 and 0.10.
That's not big deal. We can run phase 3 1) include patients show higher autoantibodies; 2) last 16/20 weeks so our worms can train patients' immune tolerance longer.
"Second, from bioinvest recent issue, I learned that Trust 2 did not do a colonoscopy to test for active Crohn's. Conversely, Trust 1(USA trial) did do a colonoscopy..."
I looked up both trials on clinicaltrialsdotgov and both listed the following identical entry criteria "Established diagnosis of Crohn's disease (CD) since at least 3 months prior to screening confirmed by endoscopic and histological, or endoscopic and radiological criteria" As long as the prior experiences are not statistical flukes or corrupted by some kind of unfortunate bias, I am hopeful both trials con show very positive results. We'll see soon enough.
here's the newsletter quote: "Dr. Falk almost reached statistical significance in April 2012 with Trust-ll (their TSO study that will take a second interim look shortly after CNDO's) without performing colonoscopies." These guys are usually pretty accurate. You can reconcile the info on the FDA site with the patients having previously done colonoscopies, without Falk actually having done them in the screening. Alternatively, one or the other is inaccurate.