Trial Protocol
Turn a lead candidate into a trial design that can actually answer whether it works and is safe.
When to use
- A candidate is ready to move toward the clinic.
- A trial design needs a first structured draft to review.
Steps
- State the primary question the trial must answer.
- Define the population, inclusion, and exclusion criteria.
- Design the arms, dosing, and randomization.
- Choose the primary and secondary endpoints.
- Specify the safety monitoring and stopping rules.
Output
A protocol outline: question, population, arms, endpoints, and safety rules, following the [[Research standards]]. A human researcher owns the lab work.