Posted On: 05/16/2016 1:43:21 PM
Post# of 72440
For those of you who don't know this, as a sponsor Leo receives case report forms for each patient in the P trial. Each report contains information such as patient number, sex, age, and most importantly, results after each visit. It's on an ongoing basis, that's how he knows the enrollment pace, among other things. Of course, he doesn't know who took what because the data are still blinded. But if more than 50% of the reports show endpoints are met (≥ 2 point improvement in IGA rating), then the likelihood of success is high.
Someone shared his experience as a patient in a trial on iHub.
"New poster here but long term investor & reader of board. I am personally involved in a phase 2 unblinded trial for a rare blood disease drug. I spoke to the clinical director involved in my trial about the process for a double blind trial. Each of the participants are identified by a #, with no disclosure by name at this point whether they receive the drug or placebo. The results are documented for each patient & the trial sponsor normally has a rep that receives the results.
What I have have observed in my personal case is that I receive an abundance of tests/labs that substantially document my continued progress. I've been in the trial for 15 months. My doctor meets with me every visit & reviews my progress. Based on my progress determines whether I can continue to participate. These results are then forwarded to the drug company for review.
Based on this discussion, I believe there is a strong possibility that results were known by someone with Cellceutix as the trial was in progress. IMO of course."
Someone shared his experience as a patient in a trial on iHub.
"New poster here but long term investor & reader of board. I am personally involved in a phase 2 unblinded trial for a rare blood disease drug. I spoke to the clinical director involved in my trial about the process for a double blind trial. Each of the participants are identified by a #, with no disclosure by name at this point whether they receive the drug or placebo. The results are documented for each patient & the trial sponsor normally has a rep that receives the results.
What I have have observed in my personal case is that I receive an abundance of tests/labs that substantially document my continued progress. I've been in the trial for 15 months. My doctor meets with me every visit & reviews my progress. Based on my progress determines whether I can continue to participate. These results are then forwarded to the drug company for review.
Based on this discussion, I believe there is a strong possibility that results were known by someone with Cellceutix as the trial was in progress. IMO of course."
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