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Investigator-Initiated Clinical Trial Awards: General Questions and Answers

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In a nutshell, how is NIAID supporting investigator-initiated clinical trials?

Investigators proposing an investigator-initiated clinical trial must go through a defined process for any of these award types:

If you need a planning phase, you may apply for a Clinical Trial Planning Grant (R34). If you're ready to begin a clinical trial, see How do I determine level of risk and choose an award type for my application?

We strongly encourage you to request a prior consultation with NIAID staff at least 10 weeks before you apply and include NIAID's summary of the consultation with your application. Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

Where can I find more information about clinical trial planning and implementation awards?

Go to Investigator-Initiated Clinical Trial Resources and contact staff listed in the Guide notices.

Why does NIAID have an investigator-initiated clinical trial process?

NIAID has an extensive infrastructure of networks and programs to support clinical trials, and we will not fund investigator-initiated research that overlaps with work funded through our infrastructure.

Additionally, we do not fund clinical trials through parent announcements, such as the R01, that allow investigators to apply on any topic of their choice.

We created the investigator-initiated clinical trial process so that we can support a limited number of investigator-initiated clinical trials. Consulting with NIAID in advance ensures that investigators do not waste their time preparing applications that we cannot consider for funding.

The process also helps investigators by enabling them to delineate the detailed plans, processes, and documentation needed to conduct a clinical trial.

Investigators who are ready to conduct a clinical trial can apply directly for one of the following:

Does the investigator-initiated clinical trial process have other benefits to PIs?

Yes. For the U01 and U44, PIs benefit from the ongoing involvement of NIAID staff.

For all the funding opportunities, program staff may be able to help you access Institute-funded resources, for example, those in existing networks, facilities, and laboratories.

Must I have permission to apply for investigator-initiated clinical trial planning and implementation awards?

No. However, we do strongly encourage you to request a prior consultation with NIAID staff. Learn more in the Investigator-Initiated Clinical Trial Planning and Implementation Awards SOP.

Do I need the R34 before I apply for an investigator-initiated clinical trial implementation award?

No. The R34 is not a prerequisite.

Can I propose an investigator-initiated clinical trial as only a part of my grant?

Possibly. While still in the planning stage of your application, you should speak to the NIAID point of contact listed in the announcement:

Are there circumstances where an investigator-initiated clinical trial is not required or appropriate?

Yes, in one of these situations:

  1. Your research might fit better into our existing clinical trial infrastructure.
  2. Your research is more appropriate for a different funding opportunity: a request for applications, a program announcement, or a solicitation.
  3. Your research might not qualify as a clinical trial under the NIH Definition of Clinical Trial.

In all cases, we highly recommend that you speak to the NIAID point of contact listed on the Guide notice to confirm.

How does the NIAID prior consultation process differ from peer review?

We discuss whether your proposed research meets NIAID's scientific priorities and should be supported with existing funds, but we do not discuss technical or scientific merit.

In contrast, as an investigator-initiated clinical trial, initial peer review assesses an application's scientific and technical merit using the initial peer review criteria stated in the Guide notice and assigns an overall impact score. For more information, see How NIH Review Criteria Affect Your Score on our Scoring and Summary Statements page.

How do I determine level of risk and choose an award type for my application?

If you discuss your plans with the scientific contact listed in one of the funding opportunity announcements, he or she can advise you on award type. Choose which award type to apply for based on level of risk.

The Clinical Trial Implementation Cooperative Agreement (U01) supports high-risk clinical trials as described in the funding opportunity announcement.

For studies that are not high risk, applicants apply for the Clinical Trial Implementation Grant (R01).

The SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) 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.)

Does the investigator-initiated clinical trial process apply to requests for applications or other solicitations?

No. It is only for investigator-initiated applications.

What types of institutions are eligible to apply for an investigator-initiated clinical trial?

Most institutions are eligible, whether academic, for-profit, non-profit, domestic or foreign. Read more in the relevant Guide announcement.

How does the investigator-initiated clinical trial process apply to small business applicants?

For the clinical trial part of your research, small businesses must use the NIAID investigator-initiated clinical trial funding opportunities:

With the exception of the U44, you cannot apply for support for an NIAID investigator-initiated clinical trial through a Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) application at this time.

For the other parts of your research, you can apply for an SBIR or STTR grant. To learn more about small business awards, visit our Small Business Awards questions and answers.

Does the investigator-initiated clinical trial process affect career development awards?

Yes. NIAID does not support independent clinical trials under most career development (K) awards (K01, K08, K22, K23, K24, K25, Parent K99/R00) as you may use these K award funds for training and career development only. If you want to conduct a clinical trial under these K award programs, it must be supported with other resources. The exception is the NIAID Physician-Scientist K99/R00 (PS K99/R00), which does allow eligible applicants to apply for support of a clinical trial. If you propose a clinical trial for the PS K99/R00 program, you must use the clinical trial FOA (to come); otherwise you must use the nonclinical trial FOA (to come). Failure to use the correct FOA under this program will result in a withdrawn application. For more details about K award programs that NIAID supports, go to Career Development Awards (K) and Career Development Grants SOP.

Who will peer review the investigator-initiated clinical trial planning and implementation award applications?

NIAID special emphasis panels will peer review all award types.

Who will hold the investigational new drug (IND) application for my clinical trial?

If the trial requires an IND, NIAID can hold it. Other arrangements are possible; discuss them with the appropriate NIAID program staff. The final decision whether NIAID will hold the IND is with NIAID.

When can I submit my application?

For both AIDS and non-AIDS applications, you may submit in September, January, and May. For specific dates, see the relevant Guide notice:

What if my question wasn't answered here, or I'd like to suggest a question?

Email with the title of this page or its URL and your question or comment. We answer questions by email and post them here. Thanks for helping us clarify and expand our knowledge base.

Content last reviewed on September 22, 2016