Budgeting

Budgeting for Randomized Controlled Trials (RCTs)

Budgeting for a Randomized Controlled Trial (RCT) requires careful planning to ensure that all necessary resources are accounted for while optimizing efficiency. A well-prepared budget supports the trial’s feasibility, transparency, and funding competitiveness.

1. Key Budget Categories

A. Personnel Costs

Personnel often represent the largest portion of an RCT budget. Salaries should be calculated based on effort and time commitment.

• Principal Investigator (PI): Budget a percentage of salary proportional to time dedicated to the trial.
• Co-Investigators: Include partial salary support if involved in study design, supervision, or analysis.
• Research Coordinator: Typically a full- or part-time role essential for trial logistics and operations.
• Biostatistician: Needed for trial design, sample size calculation, randomization, and analysis.
• Research Assistants: Handle recruitment, data collection, and participant follow-ups.
• Clinicians/Nurses: May be required for intervention delivery or outcome assessments.
• Administrative Staff: Support for scheduling, documentation, and ethics applications.
• Data Managers: Responsible for database development, management, and data cleaning.

B. Study Implementation Costs

These are operational expenses incurred during the setup and conduct of the trial.

• Recruitment: Includes advertising, outreach, and screening logistics.
• Participant Compensation: Covers incentives and transportation costs to enhance retention.
• Site Costs: Includes space rental, utilities, and supplies at clinical or research sites.
• Training and Meetings: Investigator and team training sessions, protocol reviews, and site initiation meetings.
• Ethics and Regulatory: IRB/REB submission fees and monitoring costs.
• Trial Registration: Fees for registering the trial (e.g., Clinicaltrials.gov).

C. Intervention and Data Collection Costs

This category includes any materials, services, or tools needed to deliver interventions or collect data.

• Medical Equipment and Supplies: Instruments needed for interventions or procedures.
• Medications: Includes procurement, storage, and pharmacy distribution.
• Lab Tests and Imaging: Costs for blood tests, imaging studies, or genetic testing.
• Data Collection Tools: Surveys, case report forms (CRFs), and electronic data capture systems.
• Software Licenses: Such as REDCap, SPSS, STATA, or NVivo for data analysis and management.

D. Data Management and Analysis

Ensures robust and secure data processes throughout the study lifecycle.

• Database Development: Design and maintenance of trial-specific databases.
• Data Entry and Cleaning: Staff time and tools for ensuring data quality and handling missing data.
• Statistical Analysis: Includes biostatistician time and software licenses.
• Advanced Analytics: If applicable, budget for machine learning or complex modeling.

E. Dissemination and Knowledge Translation

These costs support sharing results and engaging stakeholders.

• Manuscript Preparation: Includes open-access publishing and submission fees.
• Conferences: Travel, registration, and materials for presenting findings.
• Stakeholder Engagement: Meetings with policymakers, clinicians, or the public.
• Plain Language Summaries: For accessible reporting to non-scientific audiences.

F. Contingency Fund

A contingency fund (typically 10–15% of the total budget) should be included to cover unforeseen costs, such as recruitment delays, protocol amendments, or extended follow-up periods.

2. Budgeting Considerations

When planning the budget, several strategic and contextual factors should be considered:

• Funding Agency Requirements: Some funders limit indirect costs or require matching funds.
• Multi-site Trials: Require additional budget for coordination, travel, and site monitoring.
• Sample Size and Follow-Up Duration: Larger sample sizes and longer follow-ups increase data collection and staffing needs.
• Efficiency Strategies: Consider using electronic data collection, remote follow-up, or central randomization to reduce costs.

Conclusion

A detailed, transparent, and realistic budget is a critical component of any successful RCT. By accounting for all phases—from planning to dissemination—researchers can ensure adequate resourcing and avoid financial shortfalls that could jeopardize trial integrity or completion.