Limited Competition: Rare Diseases Clinical Research Network (RDCRN) Project Supplements for Clinical Trials to Repurpose Drugs in Collaboration with E-Rare Awardees (Admin Supp) | Apply Online

Frequently Asked Questions (FAQs)

1) What is the title of this grant opportunity?

The opportunity is titled "Limited Competition: Rare Diseases Clinical Research Network (RDCRN) Project Supplements for Clinical Trials to Repurpose Drugs in Collaboration with E-Rare Awardees (Admin Supp)."

2) What type of NIH funding opportunity is this?

This is an NIH administrative supplement opportunity. It is designed to add funds to existing RDCRN awards rather than support brand-new, stand-alone projects.

3) Is this a stand-alone grant for new applicants?

No. The opportunity is framed as a "limited competition" and an "administrative supplement," meaning it is intended for organizations that already hold RDCRN awards and are positioned to run clinical trials under those existing projects.

4) What is the main purpose of the supplement?

The purpose is to strengthen and accelerate early-stage clinical testing in rare diseases by providing additional resources to ongoing RDCRN efforts, specifically to support clinical trial sites that will test repurposed drugs.

5) What is the scientific focus of the supported clinical trials?

The focus is drug repurposing for rare diseases through clinical trials. The supplement supports evaluating an existing molecule (a known drug or compound) for potential use in treating a rare disease.

6) What clinical trial phases are supported?

The supplement funding is intended to support Phase 1 and/or Phase 2 clinical trial sites.

7) What does "repurpose drugs" mean in this context?

It means testing an existing drug or compound (not a brand-new experimental entity) for a new therapeutic use in a rare disease. The rationale described is that repurposed drugs may move into human testing faster because prior information may already exist on safety, dosing, manufacturing, or clinical use in other conditions.

8) What is unique about the collaboration model for this opportunity?

The supported trials are meant to be part of a multi-site international E-Rare-3 trial. This model links RDCRN awardees in the United States with E-Rare awardees abroad to conduct harmonized, collaborative trials across countries and institutions.

9) What is E-Rare and how does it relate to this supplement?

E-Rare is a European-led initiative that promotes international coordination in rare disease research. Under this opportunity, NIH supplement-supported trial sites are intended to collaborate with E-Rare awardees as part of an international, multi-site E-Rare-3 trial.

10) Why does the opportunity emphasize international, multi-site trials?

The description highlights a practical challenge in rare diseases: patient populations are often small and geographically dispersed. International, multi-center collaboration can be essential to enroll enough participants to produce meaningful trial results.

11) Which U.S. agency administers this opportunity?

The administering agency is the U.S. Department of Health and Human Services, National Institutes of Health (NIH).

12) Which NIH center is associated with this opportunity?

The opportunity is tied to NCATS, the National Center for Advancing Translational Sciences, aligning with NCATS's mission of translating discoveries into interventions and improving the efficiency of clinical research.

13) What funding area/category does this opportunity fall under?

It is categorized under health-related funding activity.

14) What are the CFDA numbers associated with this opportunity?

The opportunity is associated with CFDA numbers 93.350, 93.846, and 93.847.

15) Who is eligible to apply, based on the listing?

The listed eligibility includes state and local governments, public and private institutions of higher education, tribal governments and organizations, nonprofits with or without 501(c)(3) status, for-profit organizations other than small businesses, and small businesses.

16) Who is the opportunity really intended for in practice?

Although many entity types are eligible on paper, the "limited competition" and "administrative supplement" structure effectively narrows the intended applicant pool to existing RDCRN awardees whose current projects already encompass clinical trial implementation.

17) What types of activities would the supplement funds support?

The description indicates the funds are intended to support Phase 1 and/or Phase 2 clinical trial sites within ongoing RDCRN efforts, specifically to evaluate a repurposed drug for a rare disease in collaboration with E-Rare awardees as part of an international E-Rare-3 trial.

18) Is the opportunity intended to create new RDCRN projects from scratch?

No. The stated intent is to add resources to ongoing RDCRN efforts rather than start new projects from scratch.

19) When was this opportunity posted?

It was posted on April 12, 2016, and the listing indicates it was created the same day.

20) What was the application closing date?

The closing date was July 18, 2016.

21) Does the provided information include an award ceiling?

No. The provided data does not include an award ceiling.

22) Does the provided information state the expected number of awards?

No. The provided data does not state the expected number of awards.

23) If there is no award ceiling or expected number of awards listed, what does that imply?

Based on the description provided, it suggests the final funding levels and number of supplements may have depended on available NIH funds, the number of meritorious supplement requests, and the scope and needs of the proposed clinical trial sites.

24) What is the overall takeaway for applicants trying to decide fit?

This is targeted, incremental NIH funding meant to expand or enable early-phase, international, multi-site clinical testing of repurposed therapies for rare diseases, leveraging the existing RDCRN infrastructure and coordinating with E-Rare-3 partners.