News / Press Release

NCI and Investigational Drugs: What Is the Role?

March 18, 2017

The role of the National Cancer Institute (NCI) with respect to investigational drugs is that of a sponsor. NCI acts as a sponsor to many, but not all, investigational drugs moving through the FDA approval process. NCI acts as a gatekeeper for all the physicians who are participating in clinical trials for the investigational drug, and any physician wishing to obtain the product for a patient under special exemption must first obtain approval from NCI.

The physician’s request to the NCI has to obtain the following important patient information:

Having all of this information helps the NCI be sure that safety standards for each patient are upheld.

NCI and Investigational Drugs: The Role of Research

Cancer research today is steadily moving toward precision medicine where oncology therapies are designed based on the molecular makeup of the tumor, rather than the tumor’s location in the body. To support this shift, NCI provides funding for investigations and trials by developing partnerships for both pharmaceutical companies and research organizations. These partnerships have allowed NCI the opportunity to test FDA-approved oncology therapies alongside investigational products.

Additionally, NCI maintains a database, called the PDQ database, to track the status of ongoing studies. Patients and physicians alike can consult this database for any questions they may have concerning investigational drug products. NCI's Cancer Trials website, along with information specialists at NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237), are also available to provide further information.

TD2, a world-class drug development service specializing in getting the most innovative and best oncology treatments to patients in need, can also serve as a resource.

About Translational Drug Development (TD2)

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

About TD2

TD2 is an oncology development organization that provides innovative services for oncology-focused companies. Using a dedicated team of professionals with broad experience and understanding in drug development, TD2 is uniquely positioned to support improved and accelerated development of medicines for life-threatening oncology diseases. TD2 applies rigorous and high-throughput translational preclinical development, combined with regulatory affairs expertise, to customize clinical trial design and execution. TD2’s suite of capabilities encourages the timely selection of patient populations who are most likely to benefit from a new agent, and the rapid identification of clinically significant endpoints. TD2 is committed to reducing the risks and uncertainty inherent in the drug development process and to the acceleration of patient access to promising treatments. For more information, visit www.TD2inc.com.

Contact
Tara Franks
602-358-8322
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