Concept Procedures for Prospective Clinical Trials

The following procedures are designed to provide assistance and program advice to prospective applicants for Phase I, II, or III clinical trials. For Phase III clinical trials, NIDCD will give priority to NIH-defined Phase III clinical trials that are likely to have a major impact on public health policy and/or clinical practice, or that will provide important new information to practitioners and consumers.

Before applying for a grant to develop and conduct a clinical trial, investigators are encouraged—but not required—to first submit a brief description of the proposed clinical trial for programmatic review by NIDCD. This will allow program staff to guide investigators in submission of their applications.

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
• Secondary hypotheses, if any, to be investigated in the clinical trial
• Primary and secondary outcomes to be used to test the primary hypothesis
• Justification for need for the clinical trial
• Brief description of the general trial design (treatment arms, sample size, potential for patient recruitment, number of clinical sites, etc., as applicable)
• Projected cost of the trial
• Indicate if an application will be submitted for a: 1) Preliminary (Phase I/II) clinical trial, 2) Clinical Trial Planning Grant, or 3) fully developed Phase III clinical trial
• For a Preliminary (Phase I/II) clinical trial application or a Planning Grant, indicate how it will be used to assist in further development of the Phase III trial (what would be done; data to be collected, if any; etc.)

Before submitting a clinical trial concept for review, investigators are strongly encouraged to contact Gordon B. Hughes to discuss ideas for a potential clinical trial. The concept design document may be sent to Dr. Hughes at hughesg@nidcd.nih.gov.

Criteria for Programmatic Review of Clinical Trial Concepts

The following criteria will be used to review clinical trial concepts:

1. Importance of the research hypothesis to NIDCD’s mission
2. Potential impact of the trial in terms of changing clinical practice, providing new information, and/or changing public health policy
3. Feasibility of the trial in terms of design features, sample size, and recruitment
4. Uniqueness of the research to the field
5. Projected cost of the trial
6. If applicable, appropriateness of the proposed use of a Clinical Trial Planning Grant

The initial programmatic review, based on the above evaluation criteria, will be conducted by NIDCD program staff. Initial review recommendations will be forwarded to the NIDCD Director, who will decide whether the investigator should be encouraged to further develop the proposed clinical trial for submission. Even if investigators are not encouraged to submit applications for a Preliminary clinical trial, a Clinical Trial Planning Grant, or for the Phase III clinical trial, applications may always be submitted for peer review.

In accordance with NIH policy (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html), it should be noted that ALL applicants must seek agreement to accept assignment from Institute staff at least 6 weeks prior to the anticipated submission of any application requesting $500,000 or more in direct costs for any year. Applications received without indication of prior staff concurrence and identification will be returned to the investigator by the Center for Scientific Review without undergoing peer review. Therefore, NIDCD strongly encourages applicants to contact Institute staff at the earliest possible time.

A panel of scientific experts—comprising active and productive researchers in the biomedical sciences, mostly from outside the government—will conduct the scientific peer review of grant applications submitted to NIDCD. Following evaluation of scientific merit, applications receive a secondary review by the National Deafness and Other Communication Disorders Advisory Council. The Council serves in an advisory capacity to NIDCD’s Director regarding the overall merit and priority of proposed research in advancing the Institute’s research agenda.