The Pilot Project Core provides support for pilot projects in order to promote innovative and exploratory research in a rapid manner to move the field forward. To be competitive, a Center has to have sufficient funds and flexibility to engage in small scale research projects that will keep up to date with new potential medications, emerging trends in drug use, patient populations at increased risk and methodologies for assessing potential medications. For this Center we are allocating $125,000 each year for pilot studies. The amount for each award can range from $10,000-$25,000 depending on the nature and scope of the pilot. The purpose of these pilot projects is to: 1) Provide rapid preliminary results with promising new agents or therapeutic methods which could then be tested in one of the main Projects or used as preliminary data for an independent grant submission (e.g., R01 grant);2) Explore other medications-related research questions that may help elucidate mechanism or improve clinical outcome;3) Provide a unique training opportunity for Junior Faculty and Research Fellows to work on small, time-limited projects;and 4) Provide the NIDA Medication Development Division preliminary data that will be useful in designing larger trials. The Pilot Project Review Committee will consist of Dr. Evans as Chair and 3 other members of this Center (Drs. Foltin, Carpenter and Bedi) with diverse training and expertise. There will be a structured system for the application process, review process, and scientific oversight of all pilot projects. Once a pilot study has all the necessary regulatory approvals, assisted by the Research Core, the Administrative Core will handle all financial activities. Pilot studies will also utilize the Research Core for recruitment and screening procedures, database management and statistical support. Each year there will be 4 submission deadlines and applications will be formatted similar to an RO3 or R21 application. Priority will be given to proposals that focus on the thematic goals of the Center. A unique feature of this Center is that pilot project applications will be expected to include an equal number of males and females so that data can be analyzed to explore sex differences. A dedicated Pilot Project Core will encourage innovation in approaches to medication development, as exemplified by our first 3 planned pilot projects, and offer excellent training opportunities for junior researchers. Importantly, this program will also be used to evaluate novel medications as they become available.
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