Before applying for a grant to develop and conduct a clinical trial, investigators are encouraged—but not required—to submit a brief description of the proposed clinical trial for programmatic review by the NIDCD. This will allow Clinical Trials Program staff to guide investigators in submission of their applications, and will provide the NIDCD with a better understanding of the proposed clinical trial.
The document should be no more than 2 pages long and should address the following topics:
- Investigator(s) name(s) and institution(s).
- Primary hypothesis to be investigated in the clinical trial.
- Primary and secondary objectives and corresponding endpoint measures.
- Justification for this clinical trial: What are current practices/standards of care and outcomes for current practices? What impact will this clinical trial have in driving the field as well as clinical practice?
- For a preliminary (Phase I/II) clinical trial application, indicate why this clinical trial is necessary and how it will guide the development of the Phase III trial (essential information and data to be collected, if any; how this data will be used, etc.).
- For a Phase III/pivotal clinical trial application, provide a summary of studies that led to the proposed clinical trial and data from preliminary studies/summary of evidence for the potential efficacy for each proposed intervention.
- Brief description of the general trial design, including:
- Phase (e.g., Phase I, Phase II, or Phase III).
- Trial type/design (e.g., placebo-controlled, double-blinded randomized, parallel design, open-label, dose-escalation).
- Study intervention arms & rationale for each selection.
- Study population.
- Sample size (total and number in each arm).
- Randomization scheme, if applicable.
- Schema, e.g., a study flow chart or diagram.
- Primary outcome measures with performance characteristics and applicability to the target population.
- Study duration (from the enrollment visit to the last study visit).
- Number of clinical sites (specify domestic, international, or both).
- Sample size and power calculation:
- Include the expected effect size and clinical relevance of the effect size chosen.
- Feasibility for patient recruitment and anticipated enrollment per month and per year.
- Description of the intervention (including administration route, dose, duration) and risks associated with the intervention.
- Will this intervention/indication be regulated by the Food and Drug Administration (FDA), e.g., an investigational new drug (IND) or investigational device exemption (IDE)?
- If yes, provide feedback from the FDA.
- If no, provide reason that FDA oversight is not required.
- Projected direct cost per year.
- Anticipated application submission date.
Applicants requesting $500,000 or more in direct costs in any year should refer to Acceptance Requirement for Applications with $500,000 or More in Annual Direct Costs.
Email this information to Trinh T. Ly, M.D. to request a telephone consultation.