Protocol Development
Here, the scientific idea is translated into a detailed operational plan. This is the most critical feasibility stage. The protocol's inclusion/exclusion criteria, schedule of assessments (SoA), and required procedures are stress-tested. Is the I/E criteria too narrow, creating 'unicorn' patients? Is the SoA too burdensome for patients and sites? Feedback from investigators and patient advocates is crucial to designing a protocol that is both scientifically rigorous and practically executable.
Drafting clear, unambiguous, and scientifically necessary inclusion/exclusion criteria.
Designing a Schedule of Assessments (SoA) that balances data needs with patient and site burden.
Engaging with principal investigators and patient advocacy groups for feedback on the protocol's practicality.
Designing overly complex or burdensome procedures that deter participation.
Creating unrealistic patient requirements that make recruitment nearly impossible.
Having poorly defined or subjective endpoints that complicate data collection and analysis.
Test your decision-making skills in a realistic protocol development scenario.
Run a Feasibility Simulation