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The Cancer Therapy Evaluation Program (CTEP) at the National Cancer Institute: industry collaborations in new agent
1Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, Maryland 20852, USA. anshers@ctep.nci.nih.gov
Annals of the New York Academy of Sciences
|January 25, 2002
Summary
The National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) streamlines cancer drug development by coordinating clinical trials and regulatory submissions. CTEP facilitates collaboration between researchers and industry to advance investigational anticancer agents.
Area of Science:
- Oncology
- Clinical Research
- Drug Development
Background:
- The Cancer Therapy Evaluation Program (CTEP) is a key clinical research program of the National Cancer Institute (NCI).
- Its mission is to reduce the burden of cancer through coordinated clinical trials.
- CTEP plays a crucial role in the development and evaluation of new anticancer therapies.
Purpose of the Study:
- To outline the mission and functions of the Cancer Therapy Evaluation Program (CTEP).
- To describe the process of planning, reviewing, and coordinating clinical trials for investigational anticancer agents.
- To detail the collaborative framework and address industry concerns regarding partnerships with CTEP.
Main Methods:
- CTEP plans, reviews, and coordinates clinical trials from protocol inception to Investigational New Drug (IND) submission to the FDA.
- It manages, tracks, and reviews clinical protocols, ensuring regulatory compliance.
- CTEP coordinates the distribution of investigational agents from industry collaborators for NCI-sponsored trials.
Main Results:
- CTEP acts as a liaison between the FDA and the extramural research community/industry.
- It facilitates collaborations through contractual agreements like Clinical Trials Agreements (CTAs) or Cooperative Research and Development Agreements (CRADAs).
- Concerns regarding intellectual property, data access, and publications in industry collaborations are addressed.
Conclusions:
- CTEP is central to advancing cancer therapy by managing the clinical trial process.
- Collaboration with CTEP offers advantages for drug development and regulatory navigation.
- The program provides a structured framework for industry partnerships, addressing key collaborator concerns.
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