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Translational Research Initiative | |
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Overview
TRANSLATIONAL RESEARCH INITIATIVE 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
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