Release Date:  October 8, 1998

RFA:  DA-99-005


National Institute on Drug Abuse

In response to applicant inquiries, the National Institute on Drug Abuse (NIDA)
is clarifying what is meant by multisite projects for RFA DA-99-005, published
in the NIH Guide for Contracts and Grants, September 16, 1998:

In order to be considered for multisite designation under the RFA (and therefore
to allow budget to exceed $1,000,000), proposed trials will be expected to meet
the following points:

o  consist of a minimum of three separate sites

o  be geographically diverse - not located in the same city or generally in the
same state

o  be characterized by diverse subject populations across sites

o  have separate and independent staffing at the different sites

o  demonstrate power estimates that defend sample size estimates and document
recruitment history at sites identified such that recruitment within an
appropriate time frame (less than 2 years) could occur

o  estimation of power must be based on observational data, not from
theoretically based assumptions and analyses - empirically based sample estimates
will not be considered sufficient.

o  provide a strong justification for the advantage of a multisite trial at the
particular point of development of the compound in question

o  clearly indicate that funding above the $1.0M cap will be for costs associated
with additional sites - not applicant site


Inquiries concerning this notice may be directed to:

Barbara Herman, Ph.D.
Medications Development Division
National Institute on Drug Abuse
5600 Fishers Lane
Rockville, MD  20857
Telephone:  (301) 443-3318/9799
FAX:  (301) 443-2599

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