Study stage I: Design and development
Every successful trial has a clearly defined research question. This is summarised by PICO: Patient population, Intervention being tested, Comparator (placebo or active control?) and Outcome. Each element needs to be carefully considered and justified. It is also important to search the available literature and clinical trials registries. Once you have your research question and a good understanding of the current evidence you can begin to map out your study in detail and approach sources of funding and potential collaborators with confidence.