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CTEP Handbook Appendices

Appendix I. NCI - Cooperative Group - Industry Relationship Guidelines

Updated 2000

Clinical trials, which are funded by a cooperative agreement or individual grant or contract award, often utilize one or more investigational agents which are proprietary to a pharmaceutical and/or a biotech company (hereinafter, Collaborator). In this circumstance, the NCI has negotiated and executed a collaborative agreement, either a Cooperative Research and Development Agreement (CRADA) or a Clinical Trials Agreement (CTA), for the clinical co-development of the agent. The CRADA is a statutorily based mechanism created under the Federal Technology Transfer Act of 1986 for the purpose of facilitating Government-Industry collaboration and technology transfer. The CTA is an NCI-initiated mechanism for the clinical co-development of an agent.

Each CTA or CRADA defines certain obligations for the government and the Collaborator. Generally, these obligations focus on intellectual property and data rights, which may arise pursuant to these studies. Under federal funding agreement guidelines and the agreements in place between the Cooperative Groups and the NCI, certain obligations and guidelines apply to the Cooperative Groups. Compliance with any of the guidelines (in particular, publication review, data access, and intellectual property licensing) is mandatory for the Cooperative Group. Although these guidelines have been written to address NCI Cooperative Group-Industry interactions, much of the material contained in this document is also applicable to individual cancer centers and clinical investigators.

In accordance with the following obligations and guidelines, each approved protocol contains the NCI standard language for protocols, stating the existence of relevant agreement(s). A summary of these obligations and guidelines follows:
1. Proprietary Agent(s):

Often, the agent provided under a protocol sponsored by the NCI is proprietary. The agent has been provided either by the NCI or by the Collaborator for the sole purpose of the studies specified by the protocol. Neither the NCI nor the Cooperative Group may use the agent outside the scope of the protocol, nor can the agent be transferred or licensed to any party not participating in the studies under the protocol.

2. Confidentiality:

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