Method for development of a clinical database, and application of statistical probability estimation methods for design and analysis of clinical studies and assesment of treatment metrics

摘要

A method for developing a database using data from multiple sources is proposed, which can be used to generate a cohort of valid sample population to serve as a clinical database to support statistical probability analysis and evaluation of treatment metrics. This clinical database can provide the relationships between parameters and attributes that can be used to compute statistical indices to support clinical study design and analysis. The statistical modeling can reduce the number of patients to be enrolled, while the statistical analysis can be used to test analysis methods. to project outcomes, and to confirm the external validity of completed studies. This clinical database can also support the determination of treatment comparator and therapeutic treatment metrics.