Change in Application and Submission Guidelines for RFA-DK-08-011: Type 1 Diabetes TrialNet: Clinical Centers (U01)

Notice Number: NOT-DK-09-003

Key Dates
Release Date: January 27, 2009

Issued by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), (http://www2.niddk.nih.gov)

This Notice is to inform the scientific community that the NIDDK is amending the application and submission information for RFA-DK-08-011: Type 1 Diabetes TrialNet: Clinical Centers (U01), (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html), released on December 24, 2008, as follows.  The sections in bold have been added or changed in the subject RFA, along with revisions to other sections as noted.  NIDDK has also developed a Frequently Asked Questions page related to this RFA. Please see http://www2.niddk.nih.gov/Funding/FundingOpportunities/RFA/RFA_FAQ_T1D_TrialNet_Clinical_Centers for additional information.

  1. The Executive Summary has been amended to state that applicants may not submit more than one application and that applicants may not submit a resubmission application.
  2. The Research Objectives and Scope section has been clarified as follows: 

Applicants are asked to propose one study aimed at either: (1) the analysis of data and/or samples being collected by TrialNet as part of the Natural History Study and/or an ongoing or approved TrialNet intervention protocol, or (2) intervention in individuals at-risk for T1D or with newly-diagnosed T1D. Proposals will be used in the review of potential Centers and may be considered for implementation once the network and Steering Committee have been re-established.

  1. The Other Submission Requirements and Information now reads:

Each applicant should submit an application that includes the following:

(1)    A proposal to conduct a study involving either:

(a)    the analysis of data and/or samples being collected by TrialNet as part of the Natural History Study and/or an ongoing or approved TrialNet intervention protocol (http://www.diabetestrialnet.org/researchers/sample.htm) to enhance understanding of the pathogenesis and progression of T1D,

OR

(b)    an intervention in individuals at-risk for T1D or with newly-diagnosed diabetes to slow disease progression and preserve beta cell function.

The Center’s proposed protocol, including study rationale, study design, number of subjects required, projected time for completion, power analysis, and projected mechanistic studies to be done in conjunction with the trial should be included in the application. Studies proposed by successful applicants from this FOA may be considered for implementation by the TrialNet Steering Committee pending review and prioritization.

(2)    A detailed description of the Center’s prior experience in the performance of T1D clinical research studies as well as data supporting the Center’s past and present ability to recruit T1D patients for treatment studies.  The Center must demonstrate access to a population of T1D patients and family members at high risk for developing T1D.  The application should provide a detailed accounting of the Center’s recruitment and retention goals, and its plans to accomplish these, for each type of study that TrialNet conducts: new onset T1D, prevention, and natural history.

For Centers that have participated in TrialNet, a detailed recruitment report, generated by the Coordinating Center, should be included in the application. This report will include recruitment, retention, and adherence data for all TrialNet and ITN studies. For Centers that have not participated in TrialNet, a report detailing the Center’s experience in the conduct of T1D clinical research studies should be included. In addition, Centers that have not participated in TrialNet should include a recruitment plan specific to TrialNet’s ongoing and planned studies (http://www.diabetestrialnet.org/patientinfo/studies.htm).


This plan should contain details of past accomplishments and available resources that will enable the site to become an effective and productive TrialNet Clinical Center.

(3)    A description of available facilities at the Center for the conduct of TrialNet studies. This should include details regarding the availability of extended and weekend hours to accommodate patients and available support services, such as research centers, to assist TrialNet in the conduct of study-related drug administration (including infusions) and testing (such as Oral and IV Glucose Tolerance Testing and Mixed Meal Tolerance Testing).

(4)    A description of experience (if any) that the Center has had in managing one or more affiliate sites as well as a plan for recruiting and maintaining a productive network of TrialNet Affiliate Centers.

Applications should include a Principal Investigator with demonstrable experience in the conduct of T1D clinical research as well as a Co-Investigator with significant expertise in the area of T1D immunology. If the Principal Investigator is a T1D immunologist rather than an endocrinologist, the Co-Investigator should be a pediatric or adult endocrinologist with expertise in the area of T1D clinical research. The experience of both of these individuals should be described in detail in the application.  More than one Co-Investigator may be included in the application, but if multiple Co-Investigators are listed, one must fulfill the above-mentioned criteria.

(5)    A budget that includes Clinical Center infrastructure costs. Existing TrialNet Centers should request a budget that is comparable to that in the final year of the project period. For new Centers, including former TrialNet Affiliate Centers, the budget should include: (a) 0.3 FTEs of Investigator Effort (with a minimum of 0.15 FTE for the Principal Investigator and a minimum of 0.05 FTE for the primary Co-Investigator), (b) 2.0 FTEs of Trial Coordinator Effort (with a minimum of 0.5 FTEs dedicated specifically to a Recruitment Coordinator), (c) approximately $9,000 for travel to TrialNet Steering Committee Meetings (travel for two Investigators and one Coordinator to attend two meetings per year at $1500 per person per meeting), (d) $14,000 for supplies and recruitment costs, and (e) $30,000 for patient travel.

During the course of the project period, each Clinical Center’s infrastructure budgets will be adjusted annually based on productivity. The infrastructure budget for each Clinical Center will be supplemented by capitated (per patient) payments through sub-contracts from the TrialNet Biostatistics Coordinating Center based on numbers of patients enrolled and studies conducted.

  1. Please not the change to the Environment criterion under the Review and Section Process section:

Environment:
Merit of the proposed project and the extent to which overall goals and objectives of the FOA are addressed;

  1. And finally, “b-cell” has been replaced with “beta cell” throughout the document.

Applications must be prepared using the forms found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
Personal deliveries of applications are no longer permitted (see http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-040.html).

At the time of submission, two additional copies of the application and all copies of the appendix material must be sent to:

Francisco O. Calvo, Ph.D.
Chief, Review Branch
Division of Extramural Activities
National Institute of Diabetes and Digestive and Kidney Diseases
6707 Democracy Boulevard, Room Number 752, MSC 5452
Bethesda, MD 20892-5452
Telephone: (301) 594-8885
FAX: (301) 480-3505
Email: fc15y@nih.gov

All other aspects of RFA-DK-08-011 (http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-08-011.html) remain unchanged.

Inquiries

All inquiries related to this announcement should be directed to:

Ellen W. Leschek, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases
Division of Diabetes, Endocrinology and Metabolic Diseases
Room 603, MSC 5450
6707 Democracy Boulevard
Bethesda, MD 20892-5450
Telephone: (301) 402-8291
FAX: (301) 480-3503
Email: el68q@nih.gov


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