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

The Cancer Prevention and Control Clinical Trials Planning Grant Program (U34 Clinical Trials Optional) is designed to support and facilitate well-structured clinical trials aiming to improve numerous aspects of cancer prevention and control. These areas include prevention and interception, cancer-related health behaviors, early detection, healthcare delivery system, management of treatment-related symptoms, supportive care, and the long-term outcomes experienced by cancer survivors.

At the core of the grant's purpose is the recognition that investigators often lack vital information about several factors essential to create a comprehensive trial protocol. Such factors include the intended study population, potential challenges in participant accumulation, the targeted intervention, expected outcomes or endpoints, data or statistical issues, and operational risks.

Such gaps in information can lead to multiple changes in the trial protocol both before and after launch. These changes can incur more time and effort, becoming significant roadblocks to completing the study. Moreover, the grant acknowledges that testing new trial designs' suitability and feasibility may also be necessary in certain intervention contexts, at-risk groups, venues, or symptoms. These designs, aimed at reducing costs and infrastructure demands, need proper evaluation before implementation.

By conducting preparatory studies, these information gaps can be closed and unknowns better understood. This approach not only aids in producing an improved trial design but also enhances knowledge regarding the feasibility of the trial. As a result, the National Cancer Institute (NCI) can conserve substantial time and resources.