Investigator FAQs
Who is eligible? / Who can participate in the NCI Formulary?
- For clinical studies: NCI registered investigators in good standing who are 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
Can multi-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 is 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, the pharmaceutical collaborators are not required to provide funding. If funding is requested, investigators should complete the Formulary CRADA: Cost Estimate Worksheet attached to the NCI Formulary LOI form.
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?
Because 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.
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. IND exempt studies are not supported.
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 who generates the data owns the data, but they 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. To request consideration, an NCI Formulary Non-Clinical Study Proposal form is to be completed and submitted to the NCI.
Company Collaborator FAQs
How are agents in the NCI Formulary different from other NCI CRADA agents?
Agents will be provided under a separate CRADA in support of Formulary protocols. The IND for the protocol is held by the investigator/institution conducting the study, not CTEP. As such, many IND responsibilities shift to the applicant.
Will collaborators enter into agreements with the sites?
The collaborator will execute a CRADA with the NCI for the Formulary agents. The NCI will execute an NCI Formulary Material Transfer Agreement with the investigator/site. The collaborator does not need to execute separate agreements with the sites.
If a site requests funding for the protocol at the time of the LOI submission and collaborator agrees, how is it managed?
The company is not required to provide funding to the site. If collaborator agrees to provide funds to a site, the funds can be managed through the NCI Formulary CRADA to avoid a separate agreement.
Can collaborators communicate directly with investigators?
Yes, direct discussions between the collaborator and investigators will be required.
When should the collaborator expect NCI to arrange initial shipments?
NCI will arrange initial agent shipments with the collaborator once the first proposal (LOI) for the agent is approved and the MTA is executed between investigator/site and the NCI. If the NCI Formulary agent is also subject to an existing CRADA with CTEP, DCTD, or NCI, separate supplies of agent are required to support the NCI Formulary CRADA.
Is there a limit to how many or how few agents a collaborator can provide to the NCI Formulary?
No, there is no limit to the number of agents provided by a collaborator.
Will sites outside the US be participating in this initiative?
No, the protocols will only be conducted at U.S. NCI-funded ETCTN and NCTN main member sites.
Will the collaborator be notified of adverse events?
Yes, the collaborator will be informed of all routine adverse events submitted through the sponsor’s clinical data reporting system, as arranged with the pharmaceutical collaborator. The sponsor will concurrently forward all serious adverse events submitted by sponsor to the FDA to the collaborator.
What will collaborators be expected to provide with each lot of agent?
- Lot release certificate of analysis
- cGMP certificate of compliance
- Collaborator test results of ongoing stability testing for each product lot
What materials/documentation will collaborator be expected to provide?
- Agent supplies and accompanying required documentation
- Investigator’s Brochure (IB) and all updates
- Formulary Agent Material Safety Data Sheet
- Cross-reference letter to its Investigational New Drug Application (IND) or Master File for each Formulary Agent(s) to FDA with a copy to the approved investigator to file in the investigator-sponsored IND for the clinical trial(s).
Will collaborators receive updates on approved studies?
The approved investigator/sponsor is responsible for providing reports to the collaborator on the ongoing clinical trial.
Will the collaborator have an opportunity to review publications by investigator on the provided agent?
Yes, collaborators will be able to review investigator publications to ensure no confidential information is included.
Will collaborators have a right to data generated under the protocol using the provided agent?
Yes, collaborator will have a right to data generated as specified in the NCI Formulary Material Transfer Agreement.
Who will be responsible for distributing the agent to approved investigators?
NCI Pharmaceutical Management Branch (PMB) will distribute the agent to the investigators.