The document entitled `Terms of Award Option to Collaborator` is part of the financing agreement of all institutions involved in clinical trials on active substances. The Sponsored Research Agreement describes the basic procedures for auditors who collaborate directly with the pharmaceutical company and provides language that is not contrary to NCI funding agreements. Finally, the document entitled “Collaborative Clinical Development of Investigational Anticancer Agents With the NCI” is a booklet containing detailed information on the modelling agreements of the Cancer Assessment Program and other documents relevant for a fruitful collaboration with the NCI. In contrast, a CRADA is a detailed agreement between the NCI and a pharmaceutical company on the joint development of an active substance that provides for a much broader field of research, which typically encompasses preclinical development. Cooperative research and development agreements were created by contract legislation as a result of the Federal Act on Technology Transfer. Their implementation requires review and approval by the National Institutes of Health (NIH) subcommittee, and their implementation allows the NIH to receive financial support from the employee for research. ABSTRACT: The National Cancer Institute`s (NCI) Cancer Therapy Evaluation Program (CTEP) currently sponsors more than 160 Investigational New Drug (INDS) Applications and participates in approximately 1600 active protocols. In addition, it currently participates in more than 50 cooperation agreements with pharmaceutical companies. It also guarantees the confidentiality of the data and compliance with the transfer restrictions in force in accordance with the CRADA. Issues relating to the ownership of survey data and intellectual property are defined in the agreement. The NCI is responsible for the implementation of such agreements.
Any access to the data is provided by the NCI and the cooperating company (or cooperating companies). The Cancer Therapy Evaluation Program (CTEP) of the Department of Cancer Treatment and Diagnosis at the National Cancer Institute (NCI) sponsors approximately 160 Investigational New Drug (INDS) Applications and participates in approximately 1,600 active protocols. It is reviewing about 500 new protocols and includes more than 33,000 patients per year in ongoing studies. The TRP has more than 9,900 registered auditors, collaborates with about 2,000 institutions and currently participates in more than 50 cooperation agreements with pharmaceutical companies. The activity of the TRP in collaboration with the pharmaceutical company begins with the elaboration of the development plans of the investigation officer, including an exchange of information on sponsored studies. Subsequently, the CTEP is active in the development of protocols, monitoring studies and data provision to the pharmaceutical company. Protocol development is usually initiated by the receipt of a Memorandum of Understanding from an examiner for the conduct of a given study or by requests from the TRP for statements of intent for minutes. Proposals will be reviewed by the TRP ProtocolReview Committee and sent to the pharmaceutical company with an invitation to comment, following which the NCI will conduct a consensus review….