Key Dates

NOT-CA-22-062 - Notice of Intent to Publish a Funding Opportunity Announcement for Cancer Prevention and Control Clinical Trials Planning Grant (U34 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 R34 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:

• Perform studies to refine the appropriate study population, intervention, outcome, and/or study endpoint.
• Collect information necessary to identify appropriate recruitment methods and estimate available populations, screening-to-enrollment yield, attrition rate, or response rate and ensure a diverse and adequate study population.
• Identify the appropriate control or comparison group to use in the subsequent clinical trial.
• Standardize the intervention or outcome across multiple sites.
• Test the feasibility of an outcome or intervention in the field.
• Determine the acceptability of the intervention to study participants.
• Determine whether adequate adherence to an intervention is achievable.
• Standardize and validate survey instruments.
• Standardize and test the effectiveness of training tools.
• Adapt and test an intervention or outcome instrument for a population that differs culturally from the population for which the instrument was originally designed.
• Modeling data to support trial assumptions in the study design.
• Statistical planning and design

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:

• Development of a Manual of Operations
• Development of case report forms
• Data base programming
• Development of the research team
• Identification of clinical sites
• Identification of a central laboratory and other relevant service cores
• Development of study organization and governing principles, if appropriate, including a Publications Policy and an Ancillary Studies Policy
• Development of training materials and policies for staff certification and site initiation
• Establishment of a single IRB and initiation of the IRB approval process
• Obtaining study drug or other intervention materials, if appropriate
• Obtaining an Investigational New Drug Application or Investigational Device Exemption, if appropriate

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 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.

TBD

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)

240-276-7048

Email: [email protected]