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Last Updated: 10/15/21

The Treatment Referral Center and
Non-Research Use of Investigational Agents

Treatment Referral Center

The Treatment Referral Center (TRC) is a means for the NCI to provide information to community oncologists and other health care professionals about therapeutic options for cancer patients. The TRC uses several resources [Physicians Data Query (PDQ), CTEP-Information System (CTEP-IS)], and industry collaborator discussions to use a referral list of the most current active research protocols. The TRC refers patients to Cooperative Group or Cancer Center trials first. If a patient is unable to participate on a clinical trial, then the TRC will look for a non-research mechanism for the healthcare professional and patient to consider. Health care professionals may contact the TRC regarding therapeutic options, either clinical trials or non-research programs, by phone or fax.

Phone: (240) 276-6575

Non-Research Release: Non-Protocol Access to Experimental Agents

The two CTEP mechanisms for providing an agent for non-research use are Special Exception and Treatment Referral Center Protocols. These mechanisms differ in purpose, and in the reporting and procedural responsibilities of the investigator. The ultimate purpose of the non-research program is to make agents that are not FDA-approved, but have significant activity against specific malignancies, available to cancer patients and investigators. Investigators must consider the following questions when requesting an agent for non-research use:

  • Is the patient ineligible for a research protocol?
  • Have standard therapies been exhausted?
  • Does objective evidence demonstrate that the investigational agent is active in the disease for which the request is being made? CTEP usually requires published phase II data as objective evidence.
  • Is the drug likely to benefit the patient?

CTEP will consider requests for non-research use if the answers to all these questions are affirmative.

Special Exception

The Special Exception mechanism is the functional equivalent of a single patient IND, but differs in that an NCI-registered investigator obtains agent directly from CTEP without obtaining an IND from the FDA. Instead the FDA filing and other IND responsibilities are handled by CTEP. Each Special Exception is filed to an existing CTEP IND for the agent. The following information is required to consider a Special Exception request; patient identifier (initials or ID #), age, sex, diagnosis, previous cancer therapy, current clinical status, intended dose and schedule of the requested agent (based on current literature), potential concomitant therapy, and pertinent laboratory data. CTEP reviews and approves each request on a case by case basis.

Treatment Referral Center (TRC) Protocols

The NCI may make investigational treatments available via a TRC protocol for certain high priority agents or diseases. These protocols are offered to NCI-designated Clinical and Comprehensive Cancer Centers. All patients enrolled on a TRC protocol must receive their investigational therapy at an NCI designated Cancer Center.

Current TRC protocols: There are no TRC protocols open at this time.

About the Branch Chief

Tali M. Johnson, Pharm D, BCOP Dr. Johnson manages many investigational agents in support of NCI-sponsored cancer treatment trials as well as a variety of activities related to new drug development.

She holds a BA in Biology from the University of Rochester. After spending many years performing molecular biology research, she attended the University of Maryland School of Pharmacy and graduated with a PharmD. More…