Statistical Analysis Plan For Clinical Trials


Statistical Analysis Plan For Clinical Trials  

Statistical Analysis Plan (SAP) is a distinct section in a clinical research study which is approved prior to the commencement of the research. The scope of a SAP is to take an account of the details of the planned statistical analysis which are linked to any clinical research. An analysis is designed taking into consideration the desired job results and has to be conducted in a steady manner.

A SAP will typically include detailed requirements and parameters for describing the outcomes achieved during a clinical research trial, the design and subject matter of results and the tests to prove the forcefulness and the understanding of the analysis conducted.

One of the vital inclusions in a SAP is the suggested checks and particular procedures which if adopted will improve and ensure the quality of the plan and the related data.

Statistical Analysis Plan presents itself as a significant association between conduct of the clinical trial and clinical research report. A SAP is expected to provide clear support to the statistician and the programmer working for any pharmaceutical company. The report is presented as written text, mockup tables, table of content, figures and all the listings. SAP enables to open up a link between clinical, SAS programming, medical writing, and senior management of the biostatistics department.

Statistical planning begins with progress plan. It is initiated prior to the treatment of the very first subject. It consists of plans for the consistency of endpoints and definitions, assessment methods for endpoints and analysis methods for endpoints.

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