The FULL trial results can be gleaned here :
psivida 8K - (substantial detail and -stuff-)
phx.corporate-ir.net
Get the PSD version.
The CRUX of the matter is as follows:
My English
(1) The specific basis for determining whether the trial
was YES or NO is a Modified ART Data Set.
On this basis:
Trial A - Failed
Trial B - Passed
(2) Not withstanding the original criteria i.e. Modified ART Data Set.
Psivida writes .....
and have analyzed the full data set consistent with
the recommendations regarding the appropriate population
for PRIMARY ANALYSIS (my emphasis ) as described in the
FDA-adopted International Conference on Harmonization
of Technical Requirements for Registation of Pharmaceuticals for Human Use (ICH)Guidance E9, "Statisticals Principles
for Clinical Trials"
=================
On the definition above:
Trial A - Passed
Trial B - Passed
phx.corporate-ir.net
FDA
fda.gov
A 1998 Document
SNIP
5.2.1 Full Analysis Set
The intention-to-treat (see Glossary)
principle implies that the primary analysis
should include all randomized subjects.
Compliance with this principle would
necessitate complete followup of all
randomized subjects for study outcomes.
In practice, this ideal may be difficult to
achieve, for reasons to be described. In this
document, the term ‘‘full analysis set’’ is
used to describe the analysis set which is as
complete as possible and as close as possible
to the intention-to-treat ideal of including all
randomized subjects.
Preservation of the
initial randomization in analysis is important
in preventing bias and in providing a secure
foundation for statistical tests. In many
clinical trials, the use of the full analysis set
provides a conservative strategy. Under many
circumstances, it may also provide estimates
of treatment effects that are more likely to
mirror those observed in subsequent practice.
There are a limited number of
circumstances that might lead to excluding
randomized subjects from the full analysis
set, including the failure to satisfy major
entry criteria (eligibility violations), the
failure to take at least one dose of trial
medication, and the lack of any data post
randomization. Such exclusions should
always be justified. Subjects who fail to
satisfy an entry criterion may be excluded
from the analysis without the possibility of
introducing bias only under the following
circumstances:
(i) The entry criterion was measured prior
to randomization.
(ii) The detection of the relevant eligibility
violations can be made completely
objectively.
(iii) All subjects receive equal scrutiny for
eligibility violations. (This may be difficult to
ensure in an open-label study, or even in a
double-blind study if the data are unblinded
prior to this scrutiny, emphasizing the
importance of the blind review.)
(iv) All detected violations of the particular
entry criterion are excluded.
In some situations, it may be reasonable to
eliminate from the set of all randomized
subjects any subject who took no trial
medication. The intention-to-treat principle
would be preserved despite the exclusion of
these patients provided, for example, that the
decision of whether or not to begin treatment
fda.gov
fda.gov
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