Last Updated: 06/12/09

Dr. James H. Doroshow, Director,
NCI Division of Cancer Treatment and Diagnosis

Message From the DCTD Director

The Division of Cancer Treatment and Diagnosis (DCTD) focuses its activities on developing novel diagnostics and therapies for cancer. DCTD staff members, along with colleagues throughout the National Cancer Institute (NCI), academia, and industry, are working together to generate a seamless pipeline of biomarkers and therapeutics that runs the gamut from initial efforts in discovery through late-stage clinical trials. New cancer imaging techniques play a critical role in support of this pipeline as advances in image-guided diagnosis and image-guided therapies continue to emerge.

A primary goal of NCI’s DCTD is to decrease the time necessary to bring anticancer drugs and biomarkers to the clinic while enhancing our ability to predict which treatments will be most useful for each patient. At the core of this objective is the implementation of the recommendations of the Clinical Trials Working Group (CTWG) and the Translational Research Working Group (TRWG), new efforts to coordinate and enhance NCI’s drug discovery and chemical-biology engines, and our continued emphasis on first-in-human clinical trials. Furthermore, DCTD has recently completed a process in which unmet research needs in cancer therapeutics and diagnostics have been evaluated. The box accompanying this message provides a summary of these areas of investigative interest for the coming year.

Under the auspices of the CTWG, which in 2005 recommended 22 strategic initiatives for revamping the institute’s cancer clinical trials system, NCI has conducted a systematic review of the steps involved in opening a clinical trial. On average, it takes about 1,000 days for an NCI-supported clinical trial to move from inception within a cooperative group to activation in an NCI-designated cancer center. As a result of these findings, NCI Director John Niederhuber, M.D., has pledged to cut the time from inception to activation in half.

Although NCI has a robust program of clinical trials and later stage preclinical development, over the past 15 years its drug discovery efforts have received less attention. To bridge the gap between academic drug discovery and the development of anticancer agents in the clinic, NCI is in the process of reinvigorating the process of cancer drug discovery through which academia, the private sector, and government work together to enhance NCI’s capability to move novel compounds through the entire pathway from synthesis and lead molecule optimization, to target qualification, pharmacology, toxicology, formulation, and first-in-human trials.

In addition to the development of small molecule anticancer agents, DCTD is working to improve the range of immunotherapeutic approaches to cancer treatment. During a DCTD workshop conducted in July 2007, the immunotherapeutic molecules in the NCI pipeline were evaluated. Workshop participants produced a prioritized list of 20 possible immunomodulatory molecules that hold particular promise for use in cancer treatment. An organized process is now in place to either produce or obtain access to these compounds for use in future NCI-supported clinical trials.

Results from NCI’s first-ever phase 0 trial—showing that such studies appear to substantially compress the drug development timeline—were presented last year at the annual meeting of the American Society of Clinical Oncology. Several new therapeutic and imaging agents are being readied for additional NCI phase 0 studies in collaboration with the NCI Center for Cancer Research at the NIH Clinical Center.

DCTD is also playing an important role in the implementation of recommendations made last year by the TRWG. The TRWG report developed 15 recommendations that focus on “early translation”—work done to move basic research discoveries into phase I and phase II clinical trials. The work of the TRWG complements several CTWG-related activities, which are focused on “late translation,” that is, primarily phase III clinical trials. At the request of Dr. Niederhuber, DCTD is now overseeing the Specialized Programs of Research Excellence (SPORE), a major NCI vehicle for translational research. The SPOREs will be the chief component of the newly formed Translational Research Program (TRP) in DCTD.

Archived Director’s message