Importance of protocols for simulation studies in clinical drug development.

Clinical trial simulation studies can be used to assess the impact of many aspects of trial design, conduct, analysis and decision making on trial performance metrics. Simulation studies can play a vital role in improving the efficiency of the drug development process within the pharmaceutical industry, but only if they are well designed and conducted. It is imperative therefore that a protocol or simulation plan is developed, documenting how the simulation study is to be conducted, analysed and reported. This article emphasises the specific considerations necessary for designing good quality simulation studies. These include defining data generation processes, data analytic methods, decision criteria and also determining the presentation of results for all intended audiences. With clinical trial simulations becoming a vital part of the drug development process, the protocol for clinical trial simulations may in future become part of the regulatory peer review process. More rigour in the planning and execution of simulation studies will ensure that the design, analysis and decision-making process for the subsequent clinical trial is based on credible evidence that can be independently verified.