Discussion in 'Research' started by Ellen, Jun 1, 2011.
Some statements in there leave me confused.
If the US study is the same type of study, under what circumstances would the results be different?
Tom - Generally speaking, I can only say that I have heard sometimes recruiting goes on with many people from such diverse places that the standards of care are not always uniform. I heard something similar a while back about another/different "mab" agent. The person explained that some of it may come down to how they write the protocol (using primary endpoints of A1C and insulin use versus c-peptide), if insulin is the endpoint, whether the trial includes includes kids whose insulin requirements change because of hormones and growth, international centers recruiting people who may not fit the criteria, etc.
One of the other problems in all of these studies is researchers end up having to fight for people to make their visits, comply with diabetes management suggestions, etc. and it can throw things off when patients stop don't comply, stop showing up, etc.
Trying to show "statistical significance" in medicine or any field is not easy given all the variables which can arise.
Then again, it could be that the drug is not effective, but hopefully not.
It is just depressing. For a while what we have been hearing is bad news about research that failed.
I still would love to know how a drug gets to phase 3 trial with a bunch of talk of it being approved for human use and then they come to the conclusion it basically does nothing..............
Not many. Not likely. But it does happen. I was recently reading about some heart drug or diet drug or something, that had the opposite issue. They recruited people from their study all over the world. When they looked at all the data, the drug looked like a success, but if you only looked at the USA patients, then it was a failure. No one knew why, but it worked in other countries, but not here. Maybe a difference in the standard of care? or the environment? but no one knew for sure. I can't remember if the FDA approved it or not. But it was a problem.
But the reason Diamyd might still complete their USA trial is because the added cost is so small. They've already spent almost all the money they need to in order to complete the study, so they might was well pitch in a little more to finish it, and hope for some good luck.
And it looks like we now have the answer to how would a parallel trial in the US end in a different result - http://www.diamyd.com/docs/pressClip.aspx?section=investor&ClipID=584435
It ended in a similar result.
My daughter is actually in this study. Yesterday we had her regular appointment (not study related) and they informed us that they received an email the day before that they will continue to monitor the study patients but they will not be giving any more vaccines or glucose tolerance tests.
With that said, my daughter did actually receive all 4 vaccine shots and will most likely have her final study visit in September.
I was hopeful that maybe she was one of the ones getting the actual vaccine and not placebo because she is still in a very strong honeymoon. Her ratios are ISF=135, I:C 1:25.
We will still be notified once they complete the study whether or not she actually received the vaccine.
Last 5 A1C's:
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