Feasibility Studies to Inform the Design of Future Clinical Trials

The National Institutes of Health intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications that propose feasibility studies that could inform the design and conduct of subsequent definitive clinical trials (e.g., efficacy, effectiveness, pragmatic, dissemination and implementation, phase/stage II or later trials). Applications to this NOFO should demonstrate that the proposed feasibility research is scientifically necessary to design or plan the subsequent definitive clinical trial. Studies may utilize mixed methods and feasibility clinical trials to assess feasibility of recruitment, randomization, retention, intervention delivery, data collection, adherence, acceptability, and/or develop or adapt intervention components or protocols. The proposed feasibility research should enhance the rigor and reproducibility of the future trial methods. The subsequent definitive clinical trial should have the potential to make a significant impact on public health. Applications are not being solicited at this time. This notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. Investigators with expertise in clinical trial planning, design, implementation, intervention development, and/or stakeholder engagement are encouraged to begin to consider applying for this new NOFO.