Hi Everybody,
I am giving a talk at the DIA Annual Meeting in Washington in June at the
invitation of Simon Day - Statistics Head at MHRA. He is running a session
on when to specify the analysis. I am up against two regulatory speakers -
one from the MHRA and one from the FDA. The blurb about the session runs
like this:
"A formal description of a 'blind review' of the data to finalise details
of the statistical analysis was described in ICH E9. Many companies now
carry out such a review, although not all. However, there appears to be a
drift towards leaving more and more detail to be decided at the time of the
blind review, with less and less detail in the protocol. Some consider
that any decision made prior to breaking the blind for a study should be
treated in the same way, others see a general decline in credibility as
important decisions are made later and later (even if still blinded).
Regulator speakers will discuss some concerns about too much of a drift in
this direction, as they see it. Industry speakers will explain some of the
benefits, as they see them."
My working title is "10 good reasons for being late" and I would be
extremely grateful if you would help me to come up with at least some ‘good
reasons'. I may not be able to find 10 of course, but ‘good reasons’ for
being early would also be welcome.
Please reply to me (and not Allstat) at
[log in to unmask]
Kind Regards
Jorgen
============================================
Jorgen Seldrup, PhD
Development Director - Biostatistics, Europe
tel: +33 (0)3 88.77.44.06 (direct) / +33 (0)3 72.00.29.82 (mobile)
Quintiles
4, route de la Riviere - Parc Club des Tanneries
67832 Tanneries Cedex
FRANCE
tel: +33 (0)3 88.77.44.44
fax: +33 (0)3 88.77.45.11
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