Network Multisite Clinical Research Concept Proposal: Required Information

The concept proposal, a requirement of NICHD’s new Pre-Application Process for NICHD Network Multisite Clinical Research, provides an overview of the project to allow assessment of the feasibility of performing the project within an NICHD network(s), and the importance and relevance of the science to the field and to the mission of the network(s) and NICHD.

The concept proposal should be no more than five pages using standard formatting guidelines described in NOT-OD-17-030. Proposals that do not follow these guidelines will not be accepted. A sixth page should be added to provide pertinent references.

The following information is required for the concept proposal, but it may be distributed across the five pages in whatever manner the investigator believes will make the strongest case for the project.

Concept proposals are not intended to be fully developed protocols or grant applications.

Required Content

  • Project Title
  • Submitting Investigative Team: names of all Principal Investigators (PIs), their institutions, and any co-investigators, and their institutions
    • NICHD encourages inclusion of diverse and junior investigators.
    • Do not list all network investigators; include only those who are working on the concept proposal.
  • NICHD Subject Area and Alignment with Available Network(s): scientific topic and how the topic/proposal aligns with research goals of a specific network
  • Scientific Question Addressed by the Concept: one or two sentences describing the scientific question and noting its significance to the NICHD mission
  • Potential Clinical, Scientific, and Public Health Impact of the Project: brief description of the study’s potential impact
    • Overall, these initiatives intend to support projects that hold the potential to inform treatment guidelines and/or to provide new U.S. Food and Drug Administration indications and/or labeling for biomedical interventions for the patient populations of interest to the respective networks.
    • How will the study contribute to the network’s central mission?
  • Scientific Rationale/Justification
    • Describe any non-clinical data that support the proposed study, addressing the rigor of those studies and relevance of the results.
    • Describe any prior clinical studies and/or trials that support the proposed study, addressing the rigor of those studies and relevance of the results.
    • Provide references for cited work on a separate additional reference page.
  • Ongoing Trials investigating a similar intervention/patient population, or that otherwise may compete with the proposed study (if applicable)
  • Specific Aims
  • Experimental Approach
    • Study Design
      • Describe the study population and inclusion/exclusion criteria.
      • Describe the intervention being assessed (if applicable).
      • For medication and vaccine trials, provide a brief rationale for the dose(s) proposed in the study.
    • Primary Outcome
      • List and justify the primary outcome.
      • Include the duration of follow-up required to assess that outcome.
    • Secondary Outcomes
      • List and justify all secondary outcomes.
      • Include the duration of follow-up required to assess these outcomes.
    • Sample Size Estimates
      • Provide assurance and evidence that a diverse participant population reflective of the condition being studied will be recruited.
      • Provide a preliminary power determination.
    • Estimated Study Timeline and Milestones
      • Provide a projected timeline
      • Propose objective milestones, such as, but are not limited to:
        • Study activation
        • Registration on (if applicable)
        • Enrollment of 25%, 50%, 75%, and 100% of the projected study population
        • Retention target for the study population
        • Completion of data collection
        • Completion of primary outcome data analyses
        • Reporting of results in (if applicable)
    • Official Regulatory Filing needed? (For medication/device/vaccine trials only)
      • Is an Investigational New Drug (IND) or Investigational Device Exemption (IDE) Application required?
      • If so, who will maintain the IND/IDE or other regulatory filing?
    • Will there be collection and storage of biospecimens?
      • If so, what is the intended future use of the biospecimens?
  • Participating (or Potentially Participating) Pharmaceutical, Biologic or Device Manufacturing Companies, Contract Research Organizations
    • Will these companies provide study medication or other forms of support?
    • If so, briefly describe the type and amount of support.
  • Potential Non-Network Participating Sites
    • Provide evidence supporting the non-network site(s)’ ability to conduct the study.
    • Provide evidence supporting their ability to recruit diverse study participants.
  • Estimated Budget
    • Provide estimated costs and budget justification for all the following:
      • Intervention, assessment tools, and any procedures
      • Proposed per participant costs
      • Submitting site personnel
      • Any other anticipated site costs
    • The network DCC will provide additional data regarding available resources, as well as any additional network resources that must be budgeted.
    • Additional Support
      • List any additional secured or potential funding support.
      • List any proposed in-kind contributions from other parties.
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