Investigator-Initiated Clinical Trial Administrative Extensions

Purpose

To provide funds for the completion or orderly termination of investigator-initiated clinical trials when a delay occurs due to circumstances the PI could not foresee or control, the PI has adequately addressed reasons for the delay, and the clinical trial remains high priority for NIAID.

Procedure

NIAID Policy for Extension of Investigator-Initiated Clinical Trials delineates a noncompetitive process to provide funds to investigators when their clinical trial is delayed because of unanticipated or uncontrollable circumstances. After a PI adequately explains the reasons for the delay and solves the problems, NIAID may extend a high-priority clinical trial if it remains a high priority and we have sufficient funds to do so.

PIs may be a candidate for an administrative noncompetitive extension if a clinical trial was delayed for any of the following reasons:

• Difficulties obtaining suitable study agent.
• Difficulties meeting enrollment schedule.
• Difficulties obtaining assurances and certifications.
• Difficulties with access to suitable facilities.
• External hold ups at regulatory or funding agencies (not related to safety).
• Litigation involving any of the above.
• Changes in public health policy or standards of care.

NIAID does not issue administrative extensions for clinical trials delayed due to safety concerns, persistent systemic problems, or suspended grant activities. This policy does not apply to a clinical trial delayed as a result of a natural disaster; NIH will publish specific guidance in such cases. If the delay is due to vandalism or another isolated event unrelated to the trial, contact your program officer or grants management specialist.

Principal Investigators

• At least 18 months before a clinical trial grant ends, contact the person in the January 30, 2007, Guide notice to discuss the following:
  • Status of your clinical trial.
  • Reason for the delay.
  • Assurance that all problems have been addressed.
  • Estimated time and funds needed to complete the study.
• You can receive up to three years of support and may request funding up to the amount in the original grant with increases of up to 3 percent a year. You may request a budget that exceeds these amounts if you provide adequate justification.
• NIAID program staff will determine if you are a candidate for an administrative extension and invite you to submit an application if your candidacy is approved.
• After you receive an invitation, submit an abbreviated PHS 398 paper application, progress reports, all data and safety monitoring board reports, and other related documentation to NIAID, including the invitation.
• Read the PHS 398 application instructions. Your application should contain only the pages and information listed in the January 30, 2007, Guide notice.
• Submit an application at least 90 days before an upcoming advisory Council meeting. NIAID conducts an internal programmatic evaluation of the application package. Administrative extension packages do not undergo peer review; do not send your application package to the NIH Center for Scientific Review (CSR) or submit electronically. Send an original, signed application and three signed photocopies to:

  Laura Eisenman
  Grants Management Program
  Division of Extramural Activities
  National Institute of Allergy and Infectious Diseases
  Room 2120, MSC-7614
  6700-B Rockledge Drive
  Bethesda, MD 20892-7614
  Telephone: 301-402-5541
  Fax: 301-493-0597
  Email: leisenman@niaid.nih.gov
  

• The NIAID division contact will notify you in writing when the application is received, when NIAID will review the application, and the soonest possible award date.

Program Officers

• If a PI contacts you to discuss an administrative extension, refer the PI to the division contact listed below.

Program Division Contacts

• Use your internal divisional process and consult DEA OD to determine whether the clinical trial meets the Eligibility Criteria.
• If the clinical trial is eligible, use your internal divisional process to determine whether the trial fits the Candidacy Criteria for an administrative extension.
• If so, invite the PI to submit an application. Use the sample type 4 acceptance form letter, and copy the DEA OD, Budget, and GMP contacts listed below.
• After receiving the application, ensure that it undergoes meets Internal Programmatic Evaluation (IPE) Criteria. Prepare documentation of the evaluation's outcome and submit it to your management and DEA OD.
• If the outcome of the programmatic evaluation is favorable, prepare a clinical extension nomination package.
• Present the nomination package using NIAID Considerations to NIAID leadership at a meeting of the division directors, NIAID Executive Committee, or pre-Council meeting.
• If the outcome of the NIAID-level consideration is favorable, prepare a special issue worksheet. Provide the special issue worksheet and nomination package to Council for approval. Include the following:
  • Budget level and time period of three years.
  • First five pages of the extension application. If the budget page is not in the first five pages, provide all pages through the budget page.

Grants Management Staff

• After the Guide contact receives the application, provide copies to the appropriate Grants Division coordinator, who will perform an initial administrative review.
• Keep the original application in the official GMP grant file. Then provide copies of the application, along with a list of any missing information or materials, to the division contact listed below, the Grants Management coordinator, the Grants Management specialist, and DEA OD.
• If the outcome of the internal programmatic evaluation is favorable, send a copy of the application to CSR and enter any necessary information into the Council Action and Approval Program.
• If Council recommends the application for funding, work with the program division contact and program officer and use standard procedures for Method to Extend Research In Time (MERIT) extensions to make the award.

Contacts

Applicants with questions should contact the appropriate person listed below.

Send general inquiries concerning extension of clinical trials to:

Anna Ramsey-Ewing, arewing@niaid.nih.gov, 301-435-8536

For inquiries about programmatic issues contact:

DAIDS -- Martin Gutierrez, mgutierrez@niaid.nih.gov, 301-451-2703

DAIT -- Josiah Wedgwood, JWedgwood@niaid.nih.gov, 301-496-7104

DMID -- Shy Shorer, shorers@niaid.nih.gov, 301-451-3025

For inquiries about grants management issues contact:

Laura Eisenman, leisenman@niaid.nih.gov, 301-402-5541

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Investigator-Initiated Clinical Trial Administrative Extensions questions and answers

Investigator-Initiated Clinical Trials Resources