Deadline: 25-Oct-22
The National Institutes of Health (NIH) is inviting applications for the Cancer Prevention and Control Clinical Trials Planning Grant Program 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.
The FOA will support studies for the acquisition of data critical to complete the protocol of a full-scale multi-center Phase II or later phase trial. Applicants must describe the proposed future clinical trial and identify the specific issues that require additional planning. Although the scientific literature or preliminary data may provide the rationale for conducting a future clinical trial, investigators often lack critical information about the study population, intervention, outcome, or operational risks necessary to finalize the trial protocol completely. The immediate goal is that the proposed studies will yield information that is both scientifically necessary and also sufficient to permit final decisions about the design or conduct of the clinical trial that increase rigor and feasibility. Preliminary studies may be needed to fill information gaps and address unknowns this can include a pilot/ feasibility clinical trial if necessary, thereby improving trial design and rigor.
Scope
The activities required will depend on the type of study (e.g., screening study, drug/device/biologics trial, behavior intervention, cancer care delivery). The planning period should also include multi-level stakeholder engagement activities. A pilot/ feasibility trial is allowed but is not required and should only be included if it is essential to the goals of the project.
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 with a focus on ensuring a diverse and adequate study population.
- Adapt and test an intervention or outcome instrument for a population that differs culturally from the population for which the instrument was originally designed.
- Identify the appropriate control or comparison group to use in the subsequent clinical trial.
- Modeling data to support trial assumptions in the study design.
- Statistical planning and design
- 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 intervention is achievable.
- Standardize and validate survey instruments.
- Develop methods for measuring intervention fidelity.
- Standardize and test the effectiveness of training tools.
Funding Information
- Award Budget
- Application budgets are limited to $225,000 per year and $450,000 in direct costs over the 3-year project period without a clinical trial.
- Applications that include a pilot/feasibility clinical trial are limited to $225,000 per year and $600,000 in direct costs over the 3-year project period.
- Award Project Period: The maximum project period is three years.
Eligibility Criteria
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
- The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
- Nonprofits Other Than Institutions of Higher Education
- Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
- For-Profit Organizations
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
- Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
- Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
- Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
- Non-domestic (non-U.S.) Entities (Foreign Institutions)
For more information, visit https://www.grants.gov/web/grants/view-opportunity.html?oppId=341374