NOT-AI-07-012: NIAID Policy for Extension of Investigator-Initiated Clinical Trials

NIAID Policy for Extension of Investigator-Initiated Clinical Trials

Notice Number: NOT-AI-07-012 - (See Notice NOT-AI-08-037)

Key Dates
Release Date: January 30, 2007

Issued by
National Institute of Allergy and Infectious Diseases (NIAID), (http://www.niaid.nih.gov/)

Purpose

To establish and announce the NIAID Policy for Extension of Investigator-Initiated Clinical Trials (type 4) and simplify the process for submission and review of applications requesting administrative extension of investigator-initiated clinical trial grants and cooperative agreements.

Background

In 2005, NIAID announced a new policy for investigator-initiated clinical trials that put in place a two-part application and award process (see http://grants.nih.gov/grants/guide/notice-files/NOT-AI-05-021.html).

NIAID has awarded investigator-initiated clinical trial grants and cooperative agreements; in the future, all awards will be made as cooperative agreements. These awards are made to investigators with the expectation that the clinical trial will be completed within the duration and budget of the award.

Occasionally, a trial cannot be completed within the award period and budget. If the delay in trial completion occurs for reasons that the awardee could not anticipate or control and the completion of the trial is a priority for the NIAID, NIAID has determined that the traditional competing renewal application (type 2) process is more complex than is warranted. Because the initial peer review addressed all aspects of the trial, the research plan through trial completion, NIAID has established a streamlined, noncompetitive process, the NIAID Policy for Extension of Clinical Trials, to provide funds to complete ongoing trials that meet specific criteria.

Eligibility

Only awardees of NIAID investigator-initiated clinical trials will be considered for extension awards. At least 18 months before the end of the grant or cooperative agreement performance period, the awardee must contact the appropriate program official (see Inquiries) to discuss the status of the clinical trial, the reason(s) for the delay of trial completion, and the estimated additional time and funds that will be needed for study completion. If NIAID determines that the completion of the trial is a priority, the awardee will be invited to submit an abbreviated application for an administrative extension (type 4) (see below).

Application

Investigators will submit abbreviated PHS 398 grant applications along with the required additional documents, such as DSMB reports, IRB/IEC reports, etc. directly to NIAID.

Submission Process

If an investigator believes that it will not be possible to complete a trial within the performance period of the current grant or cooperative agreement award, consult the appropriate program official listed in this Notice at least 18 months before the end date of the current award to discuss the possibility of an administrative extension. At that time it is appropriate to discuss the reasons for which an extension would be requested and the criteria that must be met. If it is determined that the trial is an appropriate candidate for extension, NIAID will send an invitation to the investigator to submit an extension application package. The application must be submitted at least 90 days before an upcoming meeting of the National Advisory Allergy and Infectious Diseases Council. (For Council dates, see http://www.niaid.nih.gov/ncn/budget/default_council.htm#sched). The investigator will be notified that the application has been received, when it will be reviewed and the soonest possible award date.

Submission Requirements

If you receive an invitation letter, submit the following for consideration for an administrative extension:

An abbreviated PHS398 application (see below)
All progress reports
All DSMB reports
Other related documentation

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

The 398 application should be brief and contain only the following pages and information. Unless otherwise instructed below, complete each part of the application following the PHS 398 instructions:

Face Page
Form Page 2
Form Page 3
Form Page 4 – Provide this detailed budget information on a page 4 for the entire application and provide a form page 4 for each participating organization.
Form Page 5
Budgets Pertaining to Consortium/Contractual Arrangements
Biographical Sketch – Principal Investigator
Other Biographical Sketches – Key Personnel in alphabetical order
Resources Format Page – use continuation pages as needed
Research Plan - Sections A-D may not exceed 10 pages

A. Specific Aims – objective(s) of the original clinical trial and the proposed extension
B. Background and Significance-of the current trial and at the end of the extension period
C. Justification for the Extension–must address any reasons for delays and proposed remedies
D. Research Design and Methods – should include a description of the proposed extension
E. Human Subjects
F. Vertebrate Animals – not needed
G. Select Agent Research
H. Literature Cited
J. Consortium/Contractual Arrangements
K. Resource Sharing
L. Consultants
Checklist
Appendix –progress reports, DSMB reports and other related documentation

Do NOT send your application to the Center for Scientific review (CSR). Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package 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) 480-3780
Email: leisenman@mail.nih.gov

Inquiries

General inquiries concerning extension of clinical trials should be sent to:

Anna Ramsey-Ewing, Ph.D.
Office of the Director
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
Room 2144, MSC-7614
6700-B Rockledge Drive
Bethesda, MD 20892-7614
Telephone: (301) 435-8536
Fax: (301) 402-0369
Email: arewing@niaid.nih.gov

For inquiries about programmatic issues contact:

Martin Gutierrez
Division of AIDS
National Institute of Allergy and Infectious Diseases, NIH, DHHS
6700B Rockledge Drive
Room 4258
Bethesda, Maryland 20892-7620
Phone: (301) 451-2703
Fax: (301) 402-1505
Email: mgutierrez@niaid.nih.gov

Josiah Wedgwood, M.D., Ph.D.
Division of Allergy, Immunology and Transplantation
National Institute of Allergy and Infectious Diseases
Room 3019, MSC-6601
6610 Rockledge Drive
Bethesda, MD 20892-6601
Telephone: (301) 496-7104
FAX: (301) 480-1450
Email: JWedgwood@niaid.nih.gov

Shy Shorer, M.D., MBA
Division of Microbiology and Infectious Diseases
National Institute of Allergy and Infectious Diseases
Room 6051, MSC-6603
6610 Rockledge Drive
Bethesda, MD 20892-6603
Telephone: (301) 451-3025
FAX: (301) 480-0728
Email: ss932c@nih.gov

For inquiries about grants management issues contact:

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) 480-3780
Email: leisenman@mail.nih.gov

Additional detailed information about the NIAID Policy for Extension of Clinical Trials will be available at the NIAID Investigator-Initiated Clinical Trials website: http://www.niaid.nih.gov/ncn/clinical/R34.htm

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices

	Office of Extramural Research (OER)			National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892			Department of Health and Human Services (HHS)
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