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Considerations in Constructing Clinical Trial Budgets

The budget should reflect the full scope of activities with sufficient detail so that a reviewer can assess 1) whether all relevant components and activities were included and 2) the appropriateness of the budget for each component.

The general model for the life cycle of a clinical trial is based on the following paradigm.

General Clinical Trial Process Outline

A graphic depicting an four-step General Clinical Trial Process Outline (Design and development; Approvals, permissions, and agreements; Participant screening and enrollment; Data preparation, analysis and dissemination)

[Text version]

Proposed clinical trial budgets must account for all necessary activities and contain enough specificity in each line item to allow for appropriate review. A comprehensive budget proposal might include the following:

  1. Protocol design and development costs
    • Subject matter expert consultation
    • Background preparation
    • Protocol document preparation
    • Sample size calculation
      • Determination of sample size considerations, including
        1. Method for estimating sample size based on either
          • Estimated effect size from prior data or
          • Need to determine effect size in the target population
        2. Multi-arm study
        3. Minimal difference in effect size to be of clinical interest or significance
        4. Justification for minimal difference in effect size
      • Attrition, drop outs, and non-compliance accounted for?
        1. Estimates and factors used to determine
      • Number of informative events to analyze
        1. Per participant
        2. Total based on number of participants and number of visits per participant
    • Agreements and other legal documents: preparation and execution
    • Approvals
    • Oversight
      • External monitoring
    • Protocol training for study team
  2. Data capture and storage
    • Database preparation
    • Data security procedures
    • Logistics for each visit or encounter regarding personnel, location, supplies, processing, storage, transport, tracking
      • Location
      • Frequency
      • Equipment
      • Intervention procurement and preparation
        1. Experimental
        2. Standard therapy or intervention for the disease or condition under study
      • Procedures for administration
        1. Experimental
        2. Standard therapeutic
      • Assessments
        1. Experimental
        2. Standard therapeutic
      • Processing of collected data and specimens
        1. Data and specimen preparation
        2. Storage
        3. Packaging and shipping
      • Additional data capture
        1. From medical and administrative records
        2. From study-specific instruments that require further processing
        3. From recordings (video, auditory, still images)
  3. Analysis
    • Personnel
    • Preparation of analytic data sets
    • Methods
  4. Data dissemination
    • Presentations
    • Publications
    • Data sharing
      • Submit to pre-existing data enclave with governance structure
      • Establish independent data enclave and governance
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