Extended R01 Investigator-Initiated Clinical Trial Award SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Some links will work for NIAID staff only.

Purpose

To support investigator-initiated clinical trials (IICTs) for 6 or 7 years. For projects that require 5 or fewer years of support, check the following notices of funding opportunities (NOFOs):

Procedure

Extended R01 grants support investigator–initiated, milestone-driven, incrementally funded clinical trials of all phases that require a project period of 6 or 7 years, and, as applicable, associated mechanistic studies. NIAID supports them through the Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required) NOFO.

Examples of factors that may require a project period of 6 or 7 years include:

  • Nature of disease under study, longer follow-up required to achieve clinical and mechanistic outcomes.
  • Number and diversity of study sites.
  • Number of participants necessary for study completion.
  • Availability of target pool for the study.
  • Known difficulty with participant recruitment and/or retention.
  • Complex regulatory requirements specific to the study.

Extended R01 clinical trial implementation grants do not support planning activities for a clinical trial, such as development of study design, clinical protocol, milestone plans, research teams, informed consent, or assent documents. For those activities, principal investigators (PIs) may consider applying for an NIAID Clinical Trial Planning Grant (R34, Clinical Trial Not Allowed).

If NIAID determines that a study is high-risk, it may ask applicants to submit an NIAID Clinical Trial Implementation Cooperative Agreement (U01, Clinical Trial Required). For example, during the prior consultation phase, an NIAID program officer may note features that would necessitate a U01 or, after receiving an award, NIAID may determine substantial staff involvement is needed and convert the R01 to a U01. Refer to NIAID’s Criteria for High-Risk Clinical Trials.

If the trial requires an investigational new drug (IND), NIAID will decide who will hold the IND. PIs can discuss options with the appropriate NIAID program staff.

Prospective IICT applicants will benefit from prior consultation with program staff as described below.

After award, NIAID will consider the successful attainment of milestones as part of its annual assessment of progress. NIAID may periodically review the progress of the clinical trial.

Applicants and Principal Investigators

Before Applying

Applying

  • Follow the instructions in the Investigator-Initiated Extended Clinical Trial (R01, Clinical Trial Required) NOFO.
  • Include your prior consultation letter as an Other Attachment. Your program officer will provide this letter after your consultation.
  • Describe each stage of the clinical trial, provide criteria for completing it, and give contingency plans if you cannot meet the timeline.
  • Describe all milestones in your Study Timeline. These milestones will be incorporated into your terms of award.
  • Describe in sufficient detail all the support services that would be required for successfully implementing the proposed clinical trial.
    • Support services include but are not limited to regulatory submission, clinical site monitoring, safety monitoring, and quality management.
    • Support services do not extend to IND/investigational device exemption-enabling studies for clinical trial interventions with drugs or medical devices that the FDA has not already approved.
  • Include a sufficient and appropriate budget to support these activities.

After Award

Program Staff and Management

Contacts

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.

Links

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