U.S. National Institutes of Health
Last Updated: 09/16/08

Translational Research Initiative

Overview
Provides history/description of the Translational Research Initiative (TRI). PowerPoint slide files are also included as a quick review for the investigator and the Business Office official.

Flow Diagram
Provides a brief overview of the TRI process from the time of Letter of Intent (LOI) submission, to the completion of correlative studies, to payment of invoices.

Review Criteria
Provides a summary of the criteria for review of the LOI and of the correlative studies for which TRI support is being requested.

Available Funding
Provides categories of funding and cost estimate worksheet, and explains how the funding is provided.

Contract Deliverables
Specifically identifies the contract deliverables, which are included in the formal solicitation and contract.

Contact
Provides contact information to accommodate technical, business-related, and scientific questions.

Overview

The National Cancer Institute (NCI) supports early clinical trials for novel agent development for the treatment of patients with cancer. The identification of molecular targets for therapeutic intervention, and agents directed at those targets, is altering the paradigms for drug development. This has made it necessary for correlative studies to be performed in conjunction with these early clinical trials in order to document proof of principle, and to direct additional clinical trial strategies.

In early 2001, the NCI's Cancer Therapy Evaluation Program (CTEP) established the Translational Research Initiative (TRI) to fund correlative studies performed during the conduct of sponsored clinical trials of CTEP Investigational New Drug (IND) agents. This NCI program serves the extramural community to support critical correlative studies with material from or examinations of patients participating on NCI-sponsored clinical trials. The approved correlative studies must be linked to the clinical trials being conducted on NCI-sponsored early clinical trials, and with CTEP-IND agents, and must enhance the ongoing drug development efforts. The clinical trial awardee may request TRI funding to cover the cost of personnel time and procedures directly related to the laboratory correlative investigations, and the laboratory studies. The TRI cannot be used to support expenses associated with conducting clinical trials themselves (e.g. research nurse, data coordinator salaries). It is particularly appropriate to request TRI funding to support the performance of relevant correlative studies in the laboratory of grant supported investigators using the proposed methodology in a preclinical setting, as that will leverage the technical expertise and equipment already supported.

TRI funds are available to support laboratories that are already familiar with the procedures and assays to perform relevant correlative studies, such that the TRI supports additional samples to be assayed. The TRI was not established to assist laboratories to begin new work, nor to fund the set up of new laboratories.

A well-justified request for these funds, included in the format as outlined in the Cost Estimate Worksheet must be included in the original LOI. Investigators proposing clinical trials with translational elements that are likely to be competitive for Quick Trials funding (R21) are encouraged to apply via the Clinical Study Section for grant support. CTEP staff is available to discuss proposals that might be submitted for R21 support.

Select TRI Web Overview 10-06.ppt
Select TRI Business Office Trifold 6-04.pdf

Review Criteria

Review criteria for LOI:

  • Strong scientific hypothesis

  • Supporting preliminary data and/or a strong rationale

  • Innovative correlative studies

  • Not duplicative

  • Adequate patient accrual

  • Ability to meet regulatory requirements

  • Agent availability

  • Industry sponsor concurs

  • In 2002, 1/3 of LOIs for early clinical trials with CTEP IND agents were approved (solicited and unsolicited)

Review Criteria for Correlative Studies for TRI Support:

  • Importance of proposed correlative hypothesis for further development of agent

  • Biologic rationale for studying the target effect

  • Relevant preclinical data behind hypothesis

  • Rationale for selection of assay

  • Technical performance characteristics of assay

  • Investigator experience with the assay

  • Comparability of results with other published data

  • Impact on future studies

  • Statistics for data analysis - prevalence of target, study power for chosen endpoint

Available Funding

TRI support ALLOWS the following, with adequate justification:

  • Personnel effort appropriate and reasonable (PI support very limited)

  • Consultants

  • Equipment maintenance/service costs if appropriately justified

  • Supplies

  • Shared resource costs

  • Patient care costs

TRF WILL NOT SUPPORT the following costs:

  • Basic costs of running a clinical trial

  • Costs associated with the development of new assays

  • Costs associated with the set up of new laboratories

  • Administrative start-up fees

  • IRB preparation or filing fees

  • Patient recruitment

  • Record keeping

  • Equipment

  • Travel

  • No indirect costs may be applied to patient care costs

The Cost Estimate Worksheet is available by selecting TRI Cost Estimate Worksheet (MS Excel).

HOW IS THE FUNDING PROVIDED?

SAIC-Frederick, Inc., a subsidiary of Science Applications International Corporation (SAIC), is under contract with NCI to provide operational and technical support to many of its programs. As such, SAIC-Frederick is providing administrative support to the TRI program by creating and managing cost-reimbursement contracts to cover the costs of the approved correlative studies. See the Flow Diagram for additional information.

Contract Deliverables

CTEP TRI-SUPPORT SUBCONTRACTS SAIC-FREDERICK, INC. CONTRACT DELIVERABLES

GUIDELINES

SAIC-Frederick, Inc., a subsidiary of Science Applications International Corporation (SAIC), is under contract with NCI to provide operational and technical support to many of its programs. As such, SAIC-Frederick, Inc. is providing administrative support to the TRI program by creating and managing cost-reimbursement contracts to cover the costs of the approved correlative studies.

Appropriate contract deliverables must be provided before payment can be made on submitted invoices. Please refer to your solicitation or awarded contract for official contract language. In addition to the performance of the correlative studies described in the Statement of Work (Section C), the contract contains three required deliverables.

  • CDUS Reporting: The completion of specific studies will be documented by entering the information into the CTEP Enterprise Informatics System - CDUS. For assistance in submitting data to CDUS, please visit the CTEP site, or contact the CTEP Help Desk at ctephelp@ctisinc.com.

  • Progress Reports: The technical progress reports should outline the work accomplished during each reporting period. These reports may be brief and factual, and should be submitted electronically and within fifteen days of the end of the month. A Progress Report template has been provided for your convenience. These reports can be submitted on either a monthly or quarterly basis. Refer to Deliverables section of the contract for individually agreed upon timetable.

  • Final Report: A Final Report shall be submitted on or before the last day of the contract period. This report will include a description of the overall progress during the entire subcontract, and will include pertinent data to present significant results achieved and a scientific evaluation of the data. A summary (not to exceed 200 words) of the results achieved during the performance of this subcontract will also be included. A Final Report template has been provided for your convenience.

Progress and Final reports are distributed to the following individuals:

NOTE: FAILURE TO SUBMIT CONTRACT DELIVERABLES MAY CAUSE A DELAY IN PAYMENT

If you require further assistance, please contact Joy Beveridge, CTEP Manager at (301) 846-1623, or Eugene Anderson, Contracting Officer at (301) 846-4008.

Contact

TRANSLATIONAL RESEARCH INITIATIVE CONTACT INFORMATION

For Technical and Pre-Contract Issues:

Joy M. Beveridge, MS
CTEP Manager
Clinical Monitoring Research Program
Technical Project Officer for TRI Program
SAIC-Frederick, Inc., P.O. Box B
Fort Detrick, Maryland 21702
301/846-1623 phone
301/846-7514 fax
jbeveridge@ncifcrf.gov or jbeveridge@niaid.nih.gov

For Contract and Business Questions:

Eugene B. Anderson, CFCM
Contracting Officer
SAIC-Frederick, Inc., P.O. Box B
Frederick, Maryland 21702
301/228-4008 phone
301/228-4037 fax
eanderson@ncifcrf.gov

For Scientific Questions:

IDB Senior Clinical Investigator responsible for Agent
301/496-1196 phone
lastnamefirstinitial@ctep.nci.nih.gov



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