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Drug Availability, Labeling and Distribution

What investigational agents are available from NCI?

A list of investigational agents is available to download in MS Excel format from the industry collaborations section of the CTEP website.

How can I obtain samples of investigational agents for preclinical/not-for human use?

PMBAfterHours@mail.nih.govor by calling 301-496-5725 and asking for the NHU Pharmacist.  NHU requests may require a Material Transfer Agreement (MTA) to be signed between the NCI Technology Transfer Office and the investigator.

How do I obtain a supply of an investigational agent to treat a single patient (i.e. compassionate use)?

Single-patient requests are evaluated on a patient-by-patient basis and may be available for NCI IND agents that have shown objective clinical evidence of activity in the requested disease type.  Additional details regarding single-patient access to NCI IND agents can be found on the CTEP Web site.

How do I order an investigational agent for my study from NCI?

Agents supplied by NCI’s Cancer Therapy Evaluation Program (CTEP) may be obtained by submitting a Clinical Drug Request Form (CDR or NIH Form 986) to PMB at 301-480-4612.  The CDR form is available on the CTEP Web site.

Where do I find the policy and guidelines for investigational agent distribution from NCI?

NCI policies and guidelines for handling investigational agents can be found on the CTEP Web site.  You may also call PMB directly at 301-496-5725.

What are the NCI policy and guideline for drug procurement (i.e. accountability and storage of the agents)?

NCI policies and guidelines for drug procurement can be found on the CTEP Web site.  You may also call PMB directly at 301-496-5725.

What are the NCI policy and guideline for Agents transfer and returns?

NCI policies and guidelines for drug transfers can be found on the CTEP Web site.

How can I obtain an Investigator Brochure from NCI?

For the purpose of Institutional Review Board (IRB) or Ethics Board approval, registered NCI investigators may request an investigator brochure by e-mailing PMB at ibcoordinator@mail.nih.gov.

Requests for investigator brochures required for regulatory and investigational drug filings in your country will be referred to the manufacturer of the agent.   Please contact PMB at 301-496-5725 or pmbafterhours@mail.nih.gov for company contact information if you do not already have it.

Where can I find the NCI forms for ordering, transferring, returning and accounting for CTEP-supplied investigational agents?

These forms can be found on the CTEP Web site.