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Re: PUBLICATION RIGHTS Bruce Steinert, PhD - Urology Research 07 Jun 1995 07:06 EST

The hospital has engaged in quite a number of multicenter studies
including federal and industry funding sources. All the NIH
multicenter studies with which I have contact use a publications committee
to prepare the results of the studies. This is good for two reasons.
First, most multicenter studies are developed because a single site will
not have adequate recruitment for statistically meaningful results.
Second, it prevents the investigators from looking like idiots by
publishing results that may conflict with those of another site. The
industry sources have similar reasons for avoiding "premature evaluation"
since publication of subsets of the data could complicate their dealings with
the FDA.

However, language should be included for a "free to publish" date to
prevent sponsors from squelching results that do not support their intended
goals. Whether an individual site can make statistically valid conclusions
for publication should be up to the investigators and statisticians.

Hope that helps.
Bruce

Bruce W. Steinert, Ph.D.
Department of Urology
William Beaumont Hospital
3601 West Thirteen Mile Road        (810) 551-2572 (Voice)
Royal Oak, MI  48073-6769           (810) 551-8107 (FAX)