By now you’ve probably heard that NCCIH has a new series of funding opportunity announcements (FOAs) for investigator-initiated clinical trials. These FOAs will allow you to provide more relevant information regarding your planned trial through the use of special attachments. The review panels will use the information in the attachments to assess important aspects of your study such as rigor, feasibility, and the potential impact of your proposed trial.
I would however like to alert you to the fact that these attachments and certain components in the “Research Strategy” section of your application are considered required elements for these FOAs. This means if you don’t include them, your application will be judged incomplete or noncompliant. It will be withdrawn and won’t move forward to review!
Your Application Will Be Checked for Compliance and Completeness
When your application arrives at NIH, we’ll check it for compliance and completeness. We’ll look to see whether all required application elements are included and whether they comply with the instructions in the FOA.
For example, if the FOA requires a “Clinical Protocol Synopsis” up to 12 pages long to be included as an attachment, applications missing this attachment will be considered incomplete. And if the attachment is 30 pages long versus the 12 pages stated in the FOA, your application will be considered noncompliant.
Once you submit your application and the submission deadline has passed, it can no longer be modified, and additional, “supplemental” information can only be accepted in very limited circumstances, as outlined in NOT-OD-16-130. You can’t modify your application after it’s submitted to make it complete and compliant.
How Can You Give Your Application the Best Chance Possible in Peer Review?
- Visit our Required Application Elements links for mind and body clinical trials or natural product clinical trials. They list Required Elements and essential information for each FOA to make it easier for you to ensure all needed information is included in your application.
- Carefully read all the review criteria. Almost all of the five standard review criteria (Significance, Innovation, Investigator, Approach, and Environment) have additional instructions for applicants. Keep in mind that we ask reviewers to use these review criteria in their evaluations. So please make sure that the information we’re asking reviewers to assess is included in your application.
- Notice the “additional review criteria.” Several of these FOAs use “additional review criteria” like “milestones” and/or “Go/No-Go” criteria. These criteria do not receive criterion scores but they influence your “Overall Impact” score.
- For phased awards, plan your “milestones” carefully. Several of the new FOAs are phased awards using the R61/R33 or UG3/UH3 application mechanisms. Progression from one phase to the next will be evaluated administratively here at NCCIH based on the “milestones” and/or “Go/No-Go” criteria proposed in your application. The appropriateness of these milestones and criteria will be evaluated in peer review. Please keep in mind that clearly articulated and well planned “milestones” and/or “Go/No-Go” criteria can raise reviewers’ confidence that a potentially highly impactful but somewhat risky project would not move forward prematurely.
I hope these tips are useful. If you have questions regarding the peer review process for your application please feel free to get in touch with us.