The Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute: industry collaborations in new agent development.

The mission of the Cancer Therapy Evaluation Program (CTEP), a clinical research program of the National Cancer Institute (NCI), is to reduce the burden of cancer. CTEP plans, reviews, and coordinates clinical trials for investigational anticancer agents, from the inception of protocols through the preparation and submission of Investigational New Drug Applications (INDs) to the Food and Drug Administration (FDA). CTEP also serves as a liaison to the FDA for the extramural clinical research community and industry collaborators. Other CTEP functions include managing, tracking, and reviewing clinical protocols as well as monitoring, planning, and maintaining regulatory compliance of the clinical trials. In addition, CTEP coordinates the distribution of the investigational agents from industry collaborators for use in all NCI-sponsored clinical trials. The advantages of collaborating with CTEP are described as well as details about the contractual framework, either a Clinical Trials Agreement (CTA) or a Cooperative Research and Development Agreement (CRADA), for such a collaboration. Many of the concerns raised by industry collaborators with respect to intellectual property, data access, and publications are also addressed.