Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional)

Background
The Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) is issued by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The purpose of this funding opportunity is to facilitate well-planned clinical trials across the cancer prevention and control spectrum. This includes improving prevention, cancer-related health behaviors, screening, early detection, healthcare delivery, management of treatment-related symptoms, supportive care, and long-term outcomes for cancer survivors.

The program aims to address critical information gaps that often hinder the finalization of trial protocols, which can lead to delays and increased costs in clinical research.

Grant Details
The U34 mechanism supports planning activities necessary to finalize a full-scale multi-center Phase II or later phase trial protocol. Applicants must describe their proposed future clinical trial and identify specific issues where additional data would be beneficial for planning. Activities may include:
- refining study populations, interventions, outcomes;
- identifying recruitment methods;
- adapting interventions for diverse populations;
- modeling data for study design;
- standardizing interventions across sites;
- testing feasibility in real-world settings;
- ensuring adherence to interventions.

A pilot/feasibility trial is allowed but not required. The NOFO emphasizes the importance of a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application.

Eligibility Requirements
Eligible applicants include higher education institutions (public or private), nonprofits, for-profit organizations (including small businesses), local/state governments, tribal governments, and foreign organizations. The program encourages applications from institutions serving underrepresented groups such as Historically Black Colleges and Universities (HBCUs) and Hispanic-serving institutions. Individuals from diverse backgrounds are also encouraged to apply.

Period of Performance
The maximum project period is three years with an application budget limited to $225,000 per year and $450,000 in direct costs over the project period without a clinical trial. If a pilot/feasibility clinical trial is included, budgets can go up to $600,000 in direct costs over three years.

Grant Value
The total value of the grant is contingent upon NIH appropriations with individual awards limited to $225,000 per year without a clinical trial or $600,000 if including a pilot/feasibility trial.