NOT-CA-22-061 - Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional)
National Cancer Institute (NCI)
The National Cancer Institute (NCI) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to facilitate well planned clinical trials across the cancer prevention and control spectrum aimed at improving prevention/ interception, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and the long-term outcomes of cancer survivors. Although the scientific literature or preliminary data may provide the rationale for conducting a clinical trial, investigators often lack critical information about the study population, accrual challenges, intervention, outcome/ endpoints, data/statistical challenges or operational risks necessary to finalize the trial protocol completely. These information gaps can result in multiple protocol changes before and after trial start-up, leading to the need for additional time and expenses that may prevent study completion. Further, the suitability and feasibility of new trial designs, which minimize infrastructure and reduce costs may need to be tested in the context of a particular intervention, at-risk group, symptom or venue. Preparatory studies may fill information gaps and address unknowns, improving trial design and knowledge of trial feasibility and thus saving NCI time and money.
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.
The FOA is expected to be published in the Spring of 2022 with an expected application due date in the Summer of 2022.
This FOA will utilize the U34 activity code. Details of the planned FOA are provided below.
This Notice encourages investigators with expertise and insights into this area of cancer prevention and control late phase clinical trials to begin to consider applying for this new FOA.
NCI is committed to conducting clinical studies that have been developed with active stakeholder engagement. Active stakeholder engagement entails meaningful involvement of patients, caregivers, family members, clinicians, healthcare systems, advocacy groups, and other stakeholders relevant to the study. Stakeholder engagement is expected to help shape the design of the study, as well as recruitment and retention approaches, especially for populations who are underrepresented in research. Generally, meaningful stakeholder engagement must entail more than focus groups, surveys or other activities where stakeholders are only involved as participants or respondents. Since the complete study design and protocol must be included in the application, it is expected that investigators will have substantially engaged appropriate stakeholders prior to the submission. However, the planning period should be used to continue stakeholder engagement and make refinements to the study protocol, as appropriate.
The activities required will depend on the type of study (e.g., epidemiologic study, drug/device/biologics trial, behavior intervention). As noted above, the planning period should also include stakeholder engagement activities.
Examples of research needs include but are not limited to the following:
This FOA is intended to support applications that address research questions that are within the mission of the Division of Cancer Prevention or Division of Cancer Control and Population Sciences.
The application will need to provide the 3 plans below.
Milestone Plan: The filename "Milestone Plan.pdf" should be used.
The applicant is required to provide detailed information and timelines for completing all necessary planning activities. Milestones should be easily measurable and realistic. Milestones may include, as applicable, but are not limited to:
These milestones will be negotiated at the time of the award, as appropriate.
The Milestone plan is a separate document from the Study Timeline.
Applications that lack the Milestone Plan are considered incomplete and will not be peer-reviewed.
Organization Plan: The filename "Organization Plan.pdf" should be used.
The application must describe how the study will be organized and managed, both for the planning period and for the full study. This should include information on the leadership of the study, the proposed clinical sites, and the ability of the PD/PI to bring together the necessary study network. Describe the process for identification and selection of additional collaborators that will be added during the planning period, if applicable. The PD/PI should discuss in detail whether he/she, as well as other key members of the team, have experience in the conduct and administration of complex studies, including delineation of the success of those studies in terms of recruitment, retention, and publications.
Provide a description of the study organization and administration, including, but not limited to: a description of committee structures needed to manage the complexity of the study, including plans to assure fidelity to the protocol and integrity of the data; the role of any internal or external advisory committees; the oversight, responsibilities, and coordination of any sites or cores proposed. If an advisory committee is planned, applicants should not contact or name potential advisory committee members.
Applications that lack the Organization Plan are considered incomplete and will not be peer-reviewed.
Stakeholder Engagement Plan: The Filename "Stakeholder Engagement Plan.pdf" should be used.
The application must describe stakeholder engagement activities already conducted and how these activities influenced the development of the protocol or proposed study conduct, including recruitment. The application should also describe any stakeholder engagement efforts planned during the planning period and how these activities will be used.
Applications that lack the Stakeholder Engagement Plan are considered incomplete and will not be peer-reviewed.
The U34 planning grant would support trials that would be conducted through CP-CTNet, ULACNet, or NCORP. This could facilitate implementation of trials through these networks where critical information is missing or initial review of the concept by a steering committee, which felt the scientific premise was strong but feasibility questions remain that prevented approval. The U34 would include approval of the trial concept by the proper Steering committee. The application would need to be supported by a research base or lead academic site and have clear delineation of activities that are not currently supported through the cooperative agreement grant. Studies planned through the U34 would then follow the appropriate path through the research base or network infrastructure for funding and activation.
The total funding is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are limited to $225,000 per year and $450,000 over the 3-year project period without a clinical trial.
Applications that include a clinical trial are limited to $225,000 per year and $600,000 direct costs over the 3-year project period.
Applications are not being solicited at this time.
Please direct all inquiries to:
Brandy Heckman-Stoddard, Ph.D., M.P.H.
Division of Cancer Prevention
National Cancer Institute (NCI)