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: bh78q@nih.gov
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