DCTD Translational Research Initiative

Leidos Biomedical Research, Inc., Frederick MD

Investigators

Abstract

The 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 of agents directed at those targets, is altering the paradigms for drug development. This has made it necessary for correlative and imaging 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, CTEP/NCI established the TRI to fund correlative and imaging 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. Administrative support has been provided to CTEP/NCI's Translational Research Initiative since February 2002. An efficient pre- and post-contract mechanism has been developed to award institutions performing the correlative and imaging studies. As of August 2007, 281 awards (254 contracts plus 27 additional basic ordering agreements) had been made to 51 separate institutions, totaling more than $18 million committed. During the past year, special effort was taken to encourage all subcontractors to invoice according to contract guidelines, so that the accounting of costs across fiscal years, and the availability of programmatic funds could be better estimated. Additionally, starting in January 2007, a re-evaluation of all subcontracts was initiated to assess the priority of the proposed correlative study work for continued funding through the TRI. Considerable effort was utilized to review, coordinate, gather, and disseminate the data from this comprehensive review. This review was necessary to provide information to the Investigational Drug Steering Committee, and to evaluate the current and future fiscal obligations of the program.