Investigator Resources
Additional Resources
Investigator FAQs
Who is eligible? / Who can participate in the NCI Formulary?
For Clinical studies: NCI registered investigators in good standing from NCI-funded main member ETCTN and NCTN sites in the United States, as well as NCI intramural investigators.
For non-clinical studies: Any investigator at an accredited research institution.
What is the process to apply for access to available agents?
Eligible investigators may submit LOI proposals to CTEP, using the NCI Formulary Letter of Intent Submission Form, to conduct protocols with agents available from the NCI Formulary (alone or in combination with other NCI Formulary agents) or agents available from the NCI Formulary in combination with other marketed agents, or agents from the NCI Formulary in combination with other investigational agents (if approved by all parties).
Can muti-center trials be conducted?
Under the NCI Formulary program, a clinical protocol should be conducted in a single institution.
Is it possible to combine NCI Formulary Agents with other investigational agents that are being developed by CTEP or by industry?
It depends. NCI Formulary agents may not be used in combination with other agents obtained through the CTEP development Program. NCI Formulary agents in combination with other investigational agents from other sources may be considered if all parties involved agree to the combination trial and the language in all the agreements are consistent with the terms of the Formulary Agreement.
Is funding available?
No funding from CTEP is available. Investigators must provide evidence of funding to support trial at the time of LOI proposal submission. Investigators may request funding from the Pharmaceutical Collaborator; however, Pharmaceutical Collaborators are not required to provide funding. If funding is requested, complete the Formulary CRADA: Cost Estimate Worksheet attached to the NCI Formulary LOI form.
Will CTEP perform a scientific review of the LOI proposals and protocols?
CTEP will not perform scientific reviews on the incoming LOI proposals and protocols. The Pharmaceutical Collaborator(s) providing the agent(s) will assess the scientific validity of the proposed studies.
Will Investigators be able to communicate with Pharmaceutical Collaborators directly?
Yes, direct discussions between the Investigator and Pharmaceutical Collaborator(s) are required.
Who will prioritize access to the NCI Formulary agents?
As the supply of agents may be limited, the Pharmaceutical Collaborator(s) providing the agent(s) will prioritize access to agents based on the submitted proposals and ongoing protocols.
What reporting responsibility does the investigator have once they start their study?
Investigators are required to conduct the trial in accordance with IND regulations and the responsibilities of sponsor and report all required information to the FDA. Investigators are required to submit all clinical trial data to the NCI and Pharmaceutical Collaborator in accordance with the specified clinical data reporting system. Investigators are required to provide all other information to NCI and Pharmaceutical Collaborator in accordance with the NCI Formulary Material Transfer Agreement.
Can an Investigator make changes to a Final Protocol?
Yes, but only with the Pharmaceutical Collaborator’s prior approval.
Who will hold the IND and be responsible for regulatory submissions relating to an approved study?
The Investigator or institution will be the IND sponsor and responsible for all regulatory submissions to the FDA.
Who will be responsible for distributing the agent to approved investigators?
NCI Pharmaceutical Management Branch (PMB) will distribute the agent to the investigators.
Who will have rights to the data generated under the approved protocol?
Data rights are described in the NCI Formulary Material Transfer Agreement. In general, the Investigator that generates the data owns the data, but must provide certain rights to the Collaborator.
Are agents available for pre-clinical studies?
NCI Formulary agents will be available to investigators from NCI-funded main member ETCTN and NCTN sites for pre-clinical use in support of NCI Formulary protocols. NCI Formulary agents will be available to non-member sites for Non-Clinical Studies as well. An NCI Formulary Non-Clinical Study Proposal form is to be completed and submitted to the NCI to make the request for consideration.