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Posted On: 03/10/2017 3:09:42 PM
Post# of 72446
Re: Loose Lips #32009
The definition of clinical remission is:
"a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician's assessment using the MMDAI subscales"
The definition of clinical improvement is:
"a greater than or equal to 3 point improvement from baseline in the total MMDAI score and a greater than or equal to 1 point improvement from baseline in the rectal bleeding subscale of the MMDAI"
https://www.ncbi.nlm.nih.gov/pubmed/19491859
The Modified Mayo Disease Activity Index (MMDAI) can be seen here:
http://www.nature.com/ajg/journal/v104/n6/fig...gure-title
The POC trial is too small to be considered statistically significant. Once the optimal dosage is determined, a larger double-blind trial should be next.
"a score of 0 for rectal bleeding and a combined score of less than or equal to 2 for bowel frequency and physician's assessment using the MMDAI subscales"
The definition of clinical improvement is:
"a greater than or equal to 3 point improvement from baseline in the total MMDAI score and a greater than or equal to 1 point improvement from baseline in the rectal bleeding subscale of the MMDAI"
https://www.ncbi.nlm.nih.gov/pubmed/19491859
The Modified Mayo Disease Activity Index (MMDAI) can be seen here:
http://www.nature.com/ajg/journal/v104/n6/fig...gure-title
The POC trial is too small to be considered statistically significant. Once the optimal dosage is determined, a larger double-blind trial should be next.
Quote:
Will one of the more educated posters fill me in on what we can interpret from the 50% clinical remission and 50% partial response designations? Since this is a small trial, can this be considered statistically significant, or are they very positive results which will still need evaluation in a larger scale phase 2 study?
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