Box 27.

Exemplars on reporting item 24b

Example 1. Interim and final SAPs; IDMC roles and responsibilities; supplementary material Léauté-Labrèze et al. [94] provide several versions of the SAP for a 2-stage inferentially seamless phase 2/3 AD as supplementary material. The remit and responsibilities of the IDMC including involvement in the adaptation decision-making process are detailed. The last version (3.5) of the SAP with amendments and details of interim and final analyses is found on pages 759 to 830 of the protocol supplementary material. Simulation results are summarised on pages 831 to 836. Example 2. Simulation report; supplementary material Steg et al. [181] provide a simulation report evaluating the operating characteristics of a 3-arm 2-stage group sequential AD with dose selection under a number of scenarios in an appendix. The authors also explored the bias in methods used to estimate the treatment effects and confidence intervals and used the simulation results to inform their choice of methods. Example 3. Set-up of simulation studies and simulation results; published methodology work Gu et al. [208] describe how simulation studies were performed and presented simulation results for evaluating operating characteristics of a 2-stage Bayesian biomarker-based AD. Example 4. Simulation report; published methodology work Skrivanek et al. [154] published extensive simulation work quantifying operating characteristics of a Bayesian inferentially seamless phase 2/3 AD with RAR. Example 5. Simulation report; published methodology work Heritier et al. [63] published extensive simulation work for an inferentially seamless phase 2/3 design using frequentist methods.