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AssigneeCuramatix Clinical Solutions
InventorNikhil Singhvi
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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.
A system of compiling a clinical database using extractions from healthcare database using specifically programmed variables that can present the patient demographics and the associated diseases characteristics, diagnostic, treatment, and outcomes data for unidentified patients.
Statistical methods applied to a priori data derived from pre-existing healthcare repositories to validate the outcomes from the interim analysis in clinical study thus influencing the decision to continue or to end a clinical study.
Comparison of outcomes against other competing treatment outcomes derived from preexisting healthcare repositories for efficacy and safety.
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