CENTERS FOR THE DEVELOPMENT OF MEDICATIONS TO TREAT DRUG AND DRUG ADDICTION -
ADDENDUM

Release Date:  October 8, 1998

RFA:  DA-99-005

P.T.

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: 
https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-99-005.html.

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

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
Email:  [email protected]

Return to Volume Index

Return to NIH Guide Main Index

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)