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National Center for Complementary and Integrative Health

Concept: Feasibility Studies To Inform the Design of Future Clinical Trials

Project Concept Review

Council Approval: April 17, 2026 

Program Director: Lanay M. Mudd, Ph.D. 

Background

Definitive clinical trials must be well designed to answer clear research questions. Results should enable decisions about whether an intervention should be used in health care for a specific condition, disorder, or population. Although prior research or published literature may provide the scientific justification for a future definitive trial, investigators often lack key information needed to design and conduct that trial successfully. For example, investigators may need to develop and test the feasibility and acceptability of methods to access their target population, recruit and retain participants, deliver the intervention and control conditions, and collect data.

Feasibility studies address these gaps. They allow investigators to test key aspects of the intervention and trial design before conducting a larger clinical trial. This process improves the scientific rigor and likelihood of successful completion of the future trial.

Purpose of Proposed Initiative

The purpose of the proposed initiative is to support feasibility clinical trials that prepare for novel, high-priority future clinical trials. Feasibility trials should generate preliminary data needed to justify and design future trials, such as Phase II (Stage II), efficacy, effectiveness, pragmatic, dissemination, or implementation trials. The specific activities proposed will depend on the stage of intervention development, delivery setting, and type of the planned future trial.

This initiative aligns well with the National Institutes of Health priority of supporting replication and reproducibility in biomedical science. Supporting feasibility and acceptability testing of the future trial methods will increase the likelihood that a future trial will be reproducible and produce clear and definitive results.

Objectives

The objectives to be met by the initiative include, but are not limited to, the following: 

  • Support feasibility clinical trials that assess the feasibility and acceptability of key trial elements
  • Support other activities to facilitate feasibility and acceptability testing, such as:
    • Qualitative or mixed-methods research to refine study procedures or intervention delivery with input from key stakeholder groups
    • Intervention tailoring or adaptation when scientifically justified
    • Development of study implementation materials (e.g., protocols, manual of procedures, recruitment materials, interventionist training materials)

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