It is the responsibility of the trial statistician to ensure that the plan for analysis for the DSMB report is prepared and reviewed by the members of the DSMB, as early as possible. Many (but not all) clinical trials especially randomised trials, will have a Data and Safety Monitoring Board (DSMB) who will review trial data at pre-determined frequencies (like, interim analysis or after the recruitment of xx number of participants), to monitor the safety and progress of the trial.
It is critical that these are developed and personnel involved in data handling and analysis are adequately trained, with the help of these documents and their respective SOPs. The other key documents pertaining to data and analysis is the Data Management Plan and the Database Design and Development. Finalisation of the SAP is one of the key milestones in a trial, and is also sought during the publication process. This is done to ensure that, the knowledge of the results does not impact or influence the analysis or the presentation of the findings. The type of statistical analysis to be used for a particular trial is pre-specified. Critical statistical aspects pertaining to the trial, are included in the SAP, which is developed prior to data analysis. The designated biostatistician assumes the ultimate responsibility of all statistical aspects of the trial, including the preparation of the Statistical Analysis Plan (SAP). It is imperative to include a biostatistician or a statistical expert during all stages of a trial, i.e.
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