Last Updated: 04/06/07
CTEP Online Resources for Industry Collaborators
http://ctep.cancer.gov/industry/
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) or a cooperative research and development agreement (CRADA)
- CTEP Interaction with Industry: Provides information regarding the process for co-developing an investigational anti-cancer agent with NCI and provides links to other online resources to assist with technology development, clinical development resources, and small business research funding
- Model Agreements: A collection of 14 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 under government-industry collaborations
- CTEP Pharmacogenomics Guidelines: CTEP’s guidelines for investigators and pharmaceutical/biotechnology companies concerning the conduct of pharmacogenetics protocols linked to CTEP-sponsored clinical trials
