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NCI cooperative research and development agreements.

¹Developmental Chemotherapy Section, Investigational Drug Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, Maryland, USA. Ivyp@ctep.nci.nih.gov

Oncology (Williston Park, N.Y.)

|February 24, 2001

Summary

The National Cancer Institute

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Area of Science:

Oncology
Clinical Trials
Drug Development

Background:

The National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) manages numerous Investigational New Drug applications and active clinical protocols.
CTEP engages in over 50 collaborative agreements with pharmaceutical companies, including Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs).

Purpose of the Study:

To outline the scope and nature of CTEP's involvement in drug development and clinical trials.
To detail the structure and purpose of CRADAs and CTAs within NCI's collaborative framework.
To highlight CTEP's current engagement in oxaliplatin (Eloxatin) protocols via the CRADA program.

Main Methods:

Review of CTEP's current portfolio of Investigational New Drug applications and active protocols.
Analysis of the types and number of collaborative agreements with pharmaceutical companies.
Description of Cooperative Research and Development Agreements (CRADAs) and Clinical Trials Agreements (CTAs).

Main Results:

CTEP sponsors over 160 INDs and is involved in approximately 1,600 active protocols.
CTEP has more than 50 collaborative agreements with pharmaceutical companies.
CTEP is actively involved in oxaliplatin (Eloxatin) protocols through the CRADA program.

Conclusions:

CTEP plays a significant role in advancing cancer therapy through extensive drug development and clinical trial oversight.
CRADAs provide a framework for comprehensive clinical co-development of investigational agents, offering broader research scope than CTAs.
The program's involvement in oxaliplatin protocols demonstrates its commitment to evaluating novel cancer treatments.

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