December 16, 2019
National Cancer Institute (NCI)
The National Cancer Institute (NCI) announces an opportunity for administrative supplement funding to promote collaborations between NCI-Designated Cancer Centers (NCI-CCs) and NCI’s Cancer Therapy Evaluation Program (CTEP) Experimental Therapeutics Clinical Trials Network (ETCTN). The goals of this Early Drug Development Opportunity Program (EDDOP) offering are to accelerate the early phase development of CTEP Investigational New Drug (IND) agents, as well as provide additional participating sites for select ETCTN trials for timely patient accrual.
The ETCTN, which is supported by the NCI through its Cancer Therapy Evaluation Program (CTEP) in the Division of Cancer Treatment and Diagnosis (DCTD), has contributed to the clinical development of many anticancer agents. NCI accepts new agents into its IND portfolio through the NCI’s Experimental Therapeutics (NExT) program and develops Collaborative Research and Development Agreements (CRADAs) with pharmaceutical companies for the early clinical development of these agents. The ETCTN then melds the partnerships with pharmaceutical companies with the specialized clinical trial expertise of funded ETCTN investigators for the clinical development of novel anti-cancer therapies that are in the public interest. The ETCTN trials eligible for accrual under this initiative will be selected by the ETCTN program staff.
Specific Area of Research Interest
Pursuant to the NIH interest in accelerating cancer research, the NCI invites, through PA-18-591 in conjunction with this Notice of Special Interest (NOSI), the submission of administrative supplement requests (applications) from active NCI P30 Cancer Center Support Grants that are non-ETCTN-UM1-supported Cancer Centers for new collaborations with ETCTN-UM1-supported investigators to perform clinical research within the scientific scope of their active P30 grants that will lead to improved clinical evaluations of novel cancer drug, radiotherapy, and/or cellular therapy combinations.
In advance of considering, preparing, and submitting an administrative supplement request (i.e., application) in response to PA-18-591 in conjunction with this NOSI, inquiries from eligible awardee-applicants are strongly encouraged.
To be eligible, the parent P30 clinical Cancer Center Support Grant (CCSG) award must be able to receive funds in FY20 and be active throughout the project period of the administrative supplement. The parent award must not be in a no-cost extension period. Supplement budget requests cannot exceed $45,000 in annual direct costs. Requests must reflect the actual needs of the proposed project. Contingent on the corresponding adequate number of years remaining in the associated parent P30 award, requests are permitted for up to 6 years of support. The earliest anticipated start date is May 1, 2020. NCI intends to commit funds in FY 2020 to fund up to 10 awards.
The awarded funds may be used to offset ETCTN trial expenses at the applicant's home NCI-designated cancer center. In addition to supplement funding, resources made available under the EDDOP supplement program include access to CTEP IND agents, access for patient accrual, and complete centralized clinical trial support from the ETCTN, including Central Institutional Review Board (CIRB), centralized patient registration (OPEN), centralized data collection and data management, and regulatory support.
Eligible Individuals (Program Director/Principal Investigator)
Only Principal Investigators of NCI-designated clinical cancer centers that are not funded by an ETCTN award, as either a Lead Academic Organization (LAO) or as an Affiliated Organization (AO), are eligible for this P30 supplement.
Required Organization and Capabilities of Proposed EDDOP Accrual Sites
Applicants responding to this FOA should have appropriate capabilities and attributes. These key components are expected to ensure qualified personnel and site capabilities for the safe conduct of early phase cancer clinical trials.
Experience in the Conduct of Clinical Trials and Development of Experimental Therapeutic Agents
It is essential that investigators applying for these awards have expertise and well documented past performance in the conduct of cancer clinical trials and clinical development of experimental therapeutics. The applicant should document experience in the conduct of early phase clinical trials in oncology.
Coordination of Clinical Trials and Associated Activities
The awardees will be responsible for all administrative duties including construction and maintenance of Delegation of Tasks Logs for each open ETCTN study, filing adverse event reports, maintenance of all regulatory documents, communications, and toxicity reporting. The site must collaborate with NCI support infrastructure for the ETCTN.
Research Pharmacy Management
It is essential that all sites conducting ETCTN studies have a dedicated component to conduct investigational drug pharmacy operations required to adequately fulfill obligations related to investigational agents. Investigational pharmacy operations must be able to adequately fulfill obligations related to investigational agents, security, assuring proper transfer and/or final disposition of investigational agents, and adherence to local, state, and federal regulations. Each institution must have access to and use of a pharmacy for the use and dispensing of investigational radiopharmaceuticals used in the conduct of clinical trials if they wish to participate in studies using radiopharmaceuticals.
The minimum accrual rate for each awardee is anticipated to be five (5) patient accruals per year and the goal is seven (7) patient accruals per year. Supplement awardees are required to accept “The NCI’s Adult Central Institutional Review Board (CIRB) – Early Phase Emphasis” as the IRB of record for these studies.
The applicant should describe the number and types of oncology patients seen annually, and the tumor characterization practices and capacities at the NCI-CC. The narrative should explain how the NCI-CC will be able to enroll the goal of seven (7) patients per year to ETCTN studies selected to be included in this program. The applicant must also address procedures and policies relevant to ETCTN participation to facilitate clinical trial protocol accrual, safety, and investigational pharmaceutical management to demonstrate the capability to safely conduct early phase clinical trials.
NCI will conduct administrative reviews of applications and will support the most meritorious applications submitted for consideration, based upon availability of funds.
NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award.
Description of circumstances for which administrative supplements are available.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
Charles Kunos, M.D., Ph.D.
National Cancer Institute (NCI)