Box 18.

Exemplars on reporting item 13 (participant flowcharts)

Example 1. Inferentially seamless phase 2/3 AD Additional file 4 is an illustrative structure that could be used to show the flow of participants when reporting the final results from a trial such as ADVENT [252]. Example 2. Population enrichment AD Additional files 5 and 6 illustrate participant flowcharts that could be used for a population-enrichment adaptive trial such as TAPPAS [95], which had key hypotheses relating to the cutaneous subpopulation and full population (cutaneous and non-cutaneous) depending on whether enrichment was done or not. Example 3. Bayesian biomarker-targeted AD with RAR Additional file 7 is an adapted flow diagram from BATTLE [256] showing the number of participants that contributed to the analysis by biomarker group (subpopulations) during fixed randomisation (burn-in period) followed by RAR. Example 4. MAMS AD Additional file 8 can be adapted for reporting a MAMS trial such as TAILoR [257].