Working with the National Cancer Institute

Abstract

This chapter outlines how the National Cancer Institute (NCI) can aid researchers in academia, industry, and elsewhere in the development of promising new compounds as antineoplastic drugs. The NCI has centered this task in the Division of Cancer Treatment and Diagnosis (DCTD). The NCI is unique among the caetgorical Institutes of the National Institutes of Health in having the capacity to engage in drug discovery and development operations from screening of natural product or synthetic compound mixtures all the way through the conduct of phase III trials. Preclinical work occurs in the Developmental Therapeutics Program (DTP); the Cancer Therapy Evaluation Program (CTEP) coordinates clinical study of compounds when the NCI holds Investigational New Drug (IND) applications or when the NCI cross-files on the INDs of collaborating institutions or commercial firms. The DTP focuses on generating the data needed to file an IND application with the Food and Drug Administration (FDA), whereas the CTEP is responsible not only for filing INDs with the FDA but also for providing guidance and oversight to funded grantee institutions throughout the country for the execution of clinical trials utilizing these agents.