Feasibility Studies to Inform the Design of Future Clinical Trials
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The National Institutes of Health is planning to release a Notice of Funding Opportunity to support feasibility studies designed to inform the development of future definitive clinical trials. These studies should focus on enhancing the rigor and reproducibility of trial methods by assessing critical factors such as recruitment, randomization, retention, and intervention delivery. The goal is to ensure that subsequent trials, which must have the potential to significantly impact public health, are based on scientifically necessary preliminary research. This notice serves as a forecast to allow investigators and stakeholders to establish collaborations and develop projects before applications are officially solicited. Experts in clinical trial planning, implementation, and stakeholder engagement are encouraged to prepare. The opportunity is managed by the Department of Health and Human Services under the National Institutes of Health, with a focus on research that utilizes mixed methods or feasibility trials to refine intervention protocols.
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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.
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