CTEP Online Resources for Industry Collaborators
CTEP offers a unique combination of resources and expertise to assist industry collaborators in clinical development of new therapeutic agents and the ability to evaluate investigational agents in a wide variety of tumor types and disease settings. This section of the CTEP website provides information regarding the process for co-developing an investigational anticancer agent with NCI, for example:
NCI Standard Protocol Language for Collaborative Agreements:
NCI/DCTD standard language to be incorporated into all protocols involving agent(s) covered by a clinical trials agreement (CTA), a cooperative research and development agreement (CRADA), a clinical supply agreement (CSA) or an Agent-CRADA.
CTEP Interaction with Industry:
Provides information regarding the process for co-developing an investigational anticancer agent with NCI and provides links to other online resources such as the Investigator Handbook.
A collection of model documents in Microsoft Word for use by industry collaborators
NCI/Cooperative Group/Industry Relationship Guidelines:
Background information on government-industry collaboration and technology transfer for research involving one or more investigational agents that are proprietary to a pharmaceutical or a biotech company
Intellectual Property Option Policy:
A description of the policy governing intellectual property rights and proprietary data protections for DCTD-funded studies under government-industry collaborations
Jeffrey S. Abrams, M.D., has led the Cancer Therapy Evaluation Program (CTEP) since June 2007. Dr. Abrams came to CTEP in 1993 when he joined as a clinical research scientist to oversee the breast cancer treatment trials portfolio and participate in clinical trials at the NIH Clinical Center and the National Naval Medical Center. More…