Define the question
Begin with the decision the study needs to inform. A candidate comparison, a barrier transport question and an exposure safety question require different evidence.
- INPUT
- Candidate or material information, existing findings and the intended decision.
- WHAT HAPPENS
- Translate the question into an endpoint hierarchy and define what is inside the study scope.
- OUTPUT
- A study brief with objectives, primary endpoints and open feasibility questions.
↳ Use the agreed brief to evaluate model suitability.