TOOLS, PRODUCTS, AND RESOURCES

CTEP Online Resources for Industry Collaborators

http://ctep.cancer.gov/industryCollaborations2/default.htm

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:
  (http://ctep.cancer.gov/protocolDevelopment/docs/stdlang.doc)
  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:
  (http://ctep.cancer.gov/industryCollaborations2/industry_interaction.htm)
  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.

• Model Agreements:
  (http://ctep.cancer.gov/industryCollaborations2/model_agreements.htm)
  A collection of model documents in Microsoft Word for use by industry collaborators

• NCI/Cooperative Group/Industry Relationship Guidelines:
  (http://ctep.cancer.gov/industryCollaborations2/guidelines.htm)
  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:
  (http://ctep.cancer.gov/industryCollaborations2/default.htm#guidelines_for_collaborations)
  A description of the policy governing intellectual property rights and proprietary data protections for DCTD-funded studies under government-industry collaborations