Which statement best reflects the aim of operational feasibility in trial design?

• A. They should avoid unnecessary complexity and be practical to implement.
• B. Trial designs should seek maximum data at all costs, regardless of practicality.
• C. Feasibility considerations are optional in early trials.
• D. Operational feasibility has no impact on safety or data quality.

Answer: (B)

Operational feasibility means designing a trial in a way that can actually be carried out in real-world settings, given available resources, sites, timelines, and procedures. The statement that reflects this best is that trial designs should avoid unnecessary complexity and be practical to implement. If a design is overly complex or resource-intensive, it becomes hard to recruit, monitor, and collect data consistently, which can compromise safety oversight and data quality. A practical design supports smooth execution, timely monitoring, and reliable results.

Maximizing data at all costs ignores real-world constraints and can lead to delays, protocol deviations, and overwhelmed sites. Feasibility considerations are not optional in early trials, as early-phase work must still be doable within limited resources and settings. Saying feasibility has no impact on safety or data quality is incorrect because an impractical design can hinder proper safety monitoring and degrade data integrity.