Related SOP: Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP
Use this document to:
- Determine the appropriate award type based on your readiness to undertake a clinical trial and risk to subjects.
- Prepare ahead for your discussion with an NIAID program officer.
- Prepare your formal request for prior consultation to discuss submission of a clinical trial application.
For timing of your prior consultation request, see the Prior Consultation Timeframes for Investigator—Initiated Clinical Trial Applications.
To confirm your research meets NIH’s definition of a clinical trial, use NIH’s Decision Tool.
For general information, go to Investigator—Initiated Clinical Trial Resources.
1. Consider Award Type
Consider which award type may be appropriate.
- R34—you need a planning period funded by NIAID.
- R01—for investigators who are ready to begin a clinical trial that is not high-risk
- Extended R01—for investigators who are ready to begin a six- or seven-year clinical trial that is not high-risk
- R21—for investigators who are ready to begin a clinical trial that is not high-risk
- U01—for investigators who are ready to begin a high-risk clinical trial
- U44—for small businesses who are ready to begin a clinical trial
Go to the next steps to determine readiness and risk.
2. Assess Readiness to Implement a Clinical Trial
To be ready to undertake a clinical trial, you must have ready all documentation NIAID requires. See the Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP for a list of documents.
If you are not ready to implement a clinical trial, go to step 4 to request prior consultation from NIAID for an R34 clinical trial planning grant.
3. Assess Research Risk
Choose which award type to apply for based on level of risk. The NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required) supports high-risk clinical trials as described in the notice of funding opportunity.
For the NIAID definition of high risk, see How do I determine level of risk and choose an award type for my application?
For studies that are not high risk, applicants may apply for the NIH Research Project Grant (Parent R01, Clinical Trial Required) or an NIH Exploratory/Developmental Research Grant Program (Parent R21, Clinical Trial Required).
The NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44, Clinical Trial Required) award encourages high-risk clinical studies, though applicants may also propose studies that are not considered high risk.
NIAID may determine that substantial staff involvement is necessary for other reasons and ask you to apply for a U01 or convert your award to a U01 after award.
4. Prepare Ahead for Your Discussion With a Program Officer
Before contacting a program officer, read the Investigator—Initiated Clinical Trial Planning and Implementation Awards SOP for a list of documents you need to have ready to discuss with your NIAID program officer.
Think through all items listed below in Step 6 and gather all information you don’t already have.
5. Request Prior Consultation
As shown on Prior Consultation Timeframes for Investigator—Initiated Clinical Trial Applications, at least 10 weeks (12 weeks for an extended trial) before the receipt date, call or write the appropriate NIAID program officer. Find contact information in the program announcements listed above in step 1.
You and the program officer will have a detailed discussion about the information listed.
6. Follow Up After Prior Consultation
After you have a prior consultation with NIAID program staff, submit the following to the NIAID program officer in five pages or less:
- Study title
- Study principal investigator
- Primary institution
- Potential collaborating sites
- Proposed geographic location or locations for the clinical trial
- Phase of the proposed study, e.g., phase 1 or phase 2
- Product to be evaluated and how it will be obtained
- Industry partner, if applicable
- Study objective or objectives
- Proposed study population
- Estimated sample size
- Scientific basis for and clinical significance of the proposed clinical trial
- Potential impact on public health
- Comparison with competitive therapies and degree of similarity with other clinical trials
- Relevance to outcomes desired by the target patient population
- Study design or flow diagram depicting study
- Feasibility to successfully undertake the study
- Brief summary of risk information, e.g., available safety data, such as the product label, for the product
- General statistical assumptions for the proposed study design and analysis
- Total cost estimate of the clinical trial (not the planning grant) including, if applicable, justification for a budget of $500,000 or more. See the Big Grant Applications section below.
- Proposed start date, duration, and timeline of the clinical trial
Note for Big Grant Applications
- If you are requesting a budget of $500,000 or more in direct costs in any one year, include a section for approval of a big grant application in your request for prior consultation.
- Read the Big Grants SOP for details.
For more information, see our Investigator—Initiated Clinical Trial Resources.