National Institutes of Health

Description

The NIDCR will support R34 grants for the planning and design of clinical trials or biomarker clinical validation studies. This Funding Opportunity Announcement (FOA) will support activities to develop: the draft clinical protocol; the Clinical Investigators Brochure (or equivalent) if needed; tools for data and quality management, safety and operational oversight plans; recruitment and retention strategies; the study team; and other essential documents such as a draft Manual of Procedures that are necessary for the subsequent clinical trial or biomarker clinical validation study. The Clinical Trial or Biomarker Clinical Validation Study Planning Grant is not designed for the collection of preliminary data on the efficacy of the intervention (clinical or pre-clinical), or the collection of prospective data to support the rationale for a clinical trial or study. Evaluation of the potential subject population to determine its eligibility for participation in the future trial or biomarker validation study is allowed but not required. Planning grant activities for behavioral and social interventions may include pilot testing of the intervention during the R34 phase, thus a separate FOA (PAR-14-342) will support these types of interventional trials.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

NIH OER Webmaster <br/>FBOWebmaster@OD.NIH.GOV <br/>
FBOWebmaster@OD.NIH.GOV