Minimum Entry Criteria
Data from the most relevant in vivo models in the disease area of interest should be obtained before submitting a proposal. Efficacy should be demonstrated via the intended clinical route of administration and preferably be published in a peer-reviewed journal or independently replicated. If efficacy has been demonstrated by a route that differs from that proposed for initial clinical trials, interested investigators should provide additional data obtained by the different routes to compare exposure levels in target organs.
Disclosure of Chemical Structures
NCATS staff and external experts must have access to chemical structures to assess the scientific merit of requests. Proposals submitted without chemical structures or compositions will not be accepted. Information provided to BrIDGs in a research proposal (excluding the public abstract) is considered confidential. When BrIDGs staff seek an opinion on the scientific merit and feasibility of a project from external experts, staff do so under conflict of interest and confidentiality agreements.
The following resource limitations should be considered when requesting a BrIDGs collaboration:
- In general, manufacture of clinical trial material for any type of agent will be limited to supplies for Phase I trials. Requests to develop material for Phase II trials will be considered on a case-by-case basis.
- Toxicology studies in support of phase II or later trials (including carcinogenicity and reproductive toxicity studies) are not available.
- BrIDGs does not offer regulatory affairs support. Collaborators must identify other resources for preparing their Investigational New Drug application.
- Funding for clinical trials of any phase is not available.
- Vaccines, devices and diagnostic agents are ineligible for the program.
Additionally, projects requiring earlier-stage resources, including assay development, high-throughput screening, medicinal chemistry optimization or additional in vitro or in vivo efficacy testing are not appropriate for BrIDGs. Researchers interested in these resources should consider collaborating with other programs in the NCATS Division of Preclinical Innovation or consult with extramural program staff at the appropriate NIH Institute or Center to discuss other funding options.