- Proposals for single-center studies are sent to the NCI Formulary LOI Coordinator, Cancer Therapy Evaluation Program (CTEP), Protocol and Information Office. Eligible Investigators should review NCI Formulary agent page(s) to see if there is any required information to include in the protocol submission. This will facilitate its review by the Pharmaceutical Collaborator(s).
- The proposal may contain agents available from the NCI Formulary alone or in combination with other marketed agents. NCI Formulary agents may also be combined with other IND agents (if approved by all parties). Main member ETCTN and NCTN sites are responsible for providing any marketed agents identified in the proposal that are not available through the NCI Formulary.
- NCI will forward the proposal to the NCI Formulary Pharmaceutical Collaborator(s) for review.
- Pharmaceutical Collaborators provide scientific review of the proposals and render a decision on approval/dis-approval within 60-days.
- If the Pharmaceutical Collaborator approves the proposal, the Clinical Investigator will develop the protocol with the Pharmaceutical Collaborator(s). The Clinical Investigator must provide the initial protocol draft and the final Pharmaceutical Collaborator approved version of the protocol to the NCI for NCI Formulary agent forecasting purposes.
- All required NCI standard language for NCI Formulary protocols must be incorporated into the protocol document and informed consent prior to protocol activation.
- During development of the NCI Formulary protocol, the Clinical Investigator will execute an NCI Formulary Material Transfer Agreement with the NCI. This outlines the institution and Clinical Investigator responsibilities for conduct of the NCI Formulary protocol.
- The Institution/Clinical Investigator is responsible for filing an IND to the U.S. FDA in order to conduct the clinical investigation in accordance with obligations of 21 CFR Part 312. They are also responsible for all regulatory submissions to the FDA concerning the protocol. The Institution/Clinical Investigator will obtain cross-reference authorization for the Pharmaceutical Collaborator(s) IND or Drug Master File to the extent required for conduct of the clinical investigation. The Institution/Clinical Investigator must provide all FDA correspondence related to their IND filing and NCI Formulary protocol to the Pharmaceutical Collaborator.
- The Clinical Investigator and identified sub-investigators are required to register with the NCI to be identified as qualified to participate on the NCI Formulary Study. Clinical Investigators must also complete and maintain their own Form FDA 1572 and Form FDA 3455 as sponsor-investigator in accordance with 21CFR312 and 21CFR54, respectively. The Clinical Investigator (in the role of sponsor-investigator) must maintain an accurate list of sub-investigators participating in the clinical investigation and identify their roles and responsibilities on the NCI Formulary protocol.
- The Clinical Investigator is responsible for submission of the approved protocol to all appropriate IRBs and for obtaining such approval to conduct the clinical investigation.
- The Clinical Investigator must provide the FDA acknowledgement of IND filing letter, FDA IND safe-to-proceed notice, IRB approval, IBC approval (if required), acknowledgement from the Cancer Center the NCI Formulary protocol data submission set-up is complete for reporting to the clinical data reporting system and the Pharmaceutical Collaborator(s) approval of the final protocol version to the NCI prior to protocol activation. After the required documents are provided to the NCI and the protocol has been activated, the NCI formulary agents are available for the Investigator.
- The Clinical Investigator is responsible for submitting the NCI Formulary protocol to clinicaltrials.gov within twenty-one (21) days of initiating patient enrollment. They must report trial results as required. The Clinical Investigator must not submit the NCI Formulary protocol until it has been approved by the Pharmaceutical Collaborator.
- During conduct of the trial, the Clinical Investigator must:
- Submit all adverse events to the FDA as the sponsor in compliance with both 21 CFR § 312.32 and §312.33. Copies of all adverse event reports must be forwarded to the Pharmaceutical Collaborator within 24 hours of FDA notification.
- Submit the required protocol data, including routine and expedited adverse event reports, at specified intervals, to the NCI and the Pharmaceutical Collaborator(s). The Clinical Investigator is also responsible for all required regulatory submissions to the FDA as the IND sponsor.
- Notify the Pharmaceutical Collaborator within twenty-four (24) hours of becoming aware of any product complaint related to an NCI Formulary Agent.
- Notify the NCI and the Pharmaceutical Collaborator of any change in the protocol status or IND status.
- Submit copies of IRB continuing review approvals to the NCI and the Pharmaceutical Collaborator.
- Submit copies of any protocol amendments to the NCI that affect NCI Formulary agent supply requirements or that add participating investigators before implementation.
- Submit copies of all protocol amendments to the Pharmaceutical Collaborator for approval before implementation of the amendment.
- Submit copies of any publications as defined in the NCI Formulary Material Transfer Agreement.
- If requested by the NCI, forward copies of all safety reports submitted to the FDA per 21 CFR 312.32 to NCI for any NCI Formulary agent that is also subject to a DCTD-sponsored IND.
