Opportunity Information: Apply for RFA NS 18 017
The grant opportunity titled "Planning Grant to Develop Phase III Clinical Trials for Lewy Body Dementia (R34 clinical Trial Not Allowed)" (Funding Opportunity Number RFA-NS-18-017) is a one-year planning award from the Department of Health and Human Services, National Institutes of Health. Its aim is to fund the practical groundwork needed to launch a future Phase III clinical trial focused on treatments for Lewy Body Dementias (LBD). LBD, as defined in this announcement, includes both Dementia with Lewy Bodies and Parkinson's Disease Dementia. The key point is that this R34 is meant strictly for planning and preparation; it is not meant to fund the actual Phase III clinical trial itself.
The program supports activities that reduce risk and uncertainty before a large, expensive, multi-site Phase III study begins. Typical supported tasks include identifying and securing appropriate trial sites and collaborators, building the clinical trial team and operational structure, and developing a well-justified trial design. Applicants are expected to use the planning year to produce concrete trial-ready deliverables such as a finalized or near-final protocol, clearly defined study procedures, operational plans, and other documentation needed to move efficiently into trial implementation after the planning period ends.
A major emphasis is on designing the trial protocol and procedures in a way that is feasible for a Phase III setting. That can include selecting primary and secondary endpoints, determining inclusion and exclusion criteria, defining recruitment and retention strategies, setting up randomization and blinding approaches when appropriate, outlining intervention delivery and adherence monitoring, and creating plans for data collection and quality control. The planning period can also be used to address regulatory and compliance requirements that commonly delay large clinical trials, such as preparing for IRB review processes, drafting informed consent materials, and mapping out other approvals and oversight steps needed before enrollment can begin.
From an administrative perspective, this is a discretionary NIH grant mechanism in the health funding category, associated with CFDA numbers 93.853 and 93.866. The award ceiling is $150,000, and the opportunity anticipated making about five awards. The original posting date was December 6, 2017, with an original closing date of March 20, 2018, reflecting that it was a time-limited solicitation.
Eligibility is broad and includes many types of organizations that commonly participate in clinical research planning. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other tribal organizations; public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding higher education institutions in those categories); for-profit organizations other than small businesses; and small businesses, along with other entities as described in the full eligibility notes. This wide eligibility reflects the reality that Phase III trial planning often involves partnerships across universities, hospitals, nonprofits, and industry or other research-capable organizations.
Overall, the opportunity is designed to help applicants do the high-value preparatory work that turns an early concept for a Lewy body dementia Phase III treatment trial into an executable plan. The intended outcome is a strong, trial-ready package of protocols, site commitments, operational procedures, and regulatory pathways so that a subsequent application or funding step can focus on running the Phase III study rather than spending the first year building the foundation.Apply for RFA NS 18 017
- The Department of Health and Human Services, National Institutes of Health in the health sector is offering a public funding opportunity titled "Planning Grant to Develop Phase III Clinical Trials for Lewy Body Dementia (R34 clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853, 93.866.
- This funding opportunity was created on Dec 06, 2017.
- Applicants must submit their applications by Mar 20, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $150,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: 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 tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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