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

[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